Category Archives: labeling

EMA Improves Package Leaflets

Posted on September 23, 2011 by admin| Leave a comment

EMA Improves Package Leaflets

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The European Medicines Agency has updated the template for package leaflets for human medicines, to make the information easier for patients to understand and to include new sections on medicines’ benefits and their uses in children.

The Agency introduced these changes to contribute towards the safe and effective use of medicines. They address the feedback from five years of user testing and from a range of stakeholders, including patient and consumer groups, national medicines regulatory agencies, the pharmaceutical industry and academics.

This feedback included concerns that the package leaflet needed to be more readable with fewer rigid standard statements, and that patients needed more information on the benefits that medicines can bring and on their uses in children.

The update also takes the Agency’s report on the expectations of patients, consumers and healthcare professionals regarding benefit-risk information into account, as well as the requirements of the paediatric regulation.

The Agency’s Working Group on Quality Review of Documents introduced these changes as part of the latest revision of the human product information templates.

In addition to the package leaflet, the revision included changes to the templates for the summary of product characteristics, labelling, and ‘annex II’, the section of the product information covering the conditions imposed on marketing authorisations.

The updated templates are available in all official European Union languages, as well as Icelandic and Norwegian, together with an implementation plan. Versions of the templates showing the latest updates as ‘tracked changes’ are also available.


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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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FDA – updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)

Posted on June 19, 2011 by admin| Leave a comment

FDA – updated recommendations on the appropriate use of long-acting inhaled asthma medications medications called Long-Acting Beta-Agonists (LABAs)

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Long-Acting Beta-Agonists (LABAs), a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD), now have new recommendations in their drug label intended to promote their safe use in the treatment of asthma. The new recommendations do not apply to the use of LABAs for the treatment of COPD.

In February 2010, the agency announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma.

FDA Drug Safety Communication: Drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)

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[06/02/2010]Long-Acting Beta-Agonists (LABAs), a class of medications used for the treatment of asthma and chronic obstructive pulmonary disease (COPD), now have new recommendations in their drug label intended to promote their safe use in the treatment of asthma. The new recommendations do not apply to the use of LABAs for the treatment of COPD.

In February 2010, the agency announced it was requiring manufacturers to revise their drug labels because of an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations, in pediatric and adult patients, as well as death in some patients using LABAs for the treatment of asthma.

The new recommendations in the updated labels state:

  • Use  of a LABA alone without use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (absolutely advised against) in the treatment of asthma.
  • LABAs should not be used in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.
  • LABAs should only be used as additional therapy for patients with asthma who are currently taking but are not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid.
  • Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.
  • Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure adherence with both medications.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Concept Paper on Potency Declaration / Labelling for Modified Biologicals

Posted on May 30, 2011 by admin| Leave a comment

EMA Concept Paper on Potency Declaration / Labelling for Modified Biologicals

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There is an increasing interest of Industry to develop new biopharmaceuticals based on modifications of established protein therapeutics with the aim to alter the in vivo properties of these products. The introduced modifications could be a removal or replacement of one, or a few, amino acids in the molecule, which is achieved by modification of the gene, or by chemical modifications such as conjugation to a carrier molecule (e.g. pegylation) applied after biosynthesis of the protein. Some of these modified products have already entered the market, many more are in clinical development. Well known examples of modified products are insulin analogues and pegylated (PEG) proteins. EMA guidance documents related to aspects of potency labelling and declaration of composition for these classes of compounds have been published (ref 1, 2). Currently, more representatives for PEG modified biopharmaceuticals are under development, e.g. pegylated coagulation factors. The issue of calibration / standardisation and labelling of such products has been the subject of a number of Scientific Advices given by CHMP. Modified products could be considered as analoguous to the “parent” products in particular when they are intended for the same therapeutic indication and are given the same activity unitage as their parent counterpart, leading to potential confusion and misinterpretation in the dosing in daily practice. Thorough consideration should be given to the expression of strength of modified products in units of activity. Modified products will likely have similar responses as their “parent” compounds in in vitro biological assays for potency assignment, where the structural modification(s) do not modify the interaction between the test molecule and the effector. Nevertheless, units thus assigned in vitro may correlate differently with the clinical activity for the modified and the parent compound, particularly if the modification has changed the pharmacokinetic profile. This concept paper aims to provide the rationale for drafting a guidance document for potency assignment of modified proteins for which an International Standard exists or where a clinical recognised unit exists (without an International Standard established) for the non-modified product. It should be noted that the terminology “modified proteins”, used throughout this concept paper, refers to proteins which are modified in any way (e.g. pegylated or amino acid modifications) in order to alter the in vivo properties of these molecules. The terminology “parent product” refers to the non modified protein which the modified protein is derived from and for which the first (International) Unitage has been established.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Recommendation of Labelling and Packaging for Non-Prescription Medicines Released

Posted on May 26, 2011 by admin| Leave a comment

EMA Recommendation of Labelling and Packaging for Non-Prescription Medicines Released

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The European Medicines Agency has released recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products for a three-month public consultation period.

The draft document summarises recommendations for companies preparing mock-ups and specimens of the packaging of non-prescription medicines authorised through the centralised procedure. It was developed after consulting Member States on national practices regarding pack design and labelling.

Pack design and labelling are key elements in ensuring the safe use of medicines, since they can be used to reduce the risk of confusion and error. They are particularly important for medicines that are available without a prescription, especially when no intervention from a pharmacist is needed.

The document was prepared by the Working Group on Quality Review of Documents (QRD). It is open for consultation until 30 June 2011.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Guidance on On-Pack Design and Labelling

Posted on May 25, 2011 by admin| Leave a comment

EMA Publish Guidance on On-Pack Design and Labelling

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Pack design and labelling ensure that the critical information necessary for the safe use of a medicine is legible, easily accessible and that users of medicines can easily assimilate this information so that any risk of confusion and error is minimised.
For non-prescription medicines the clear identification and selection of the appropriate medicine is very important, especially in cases where there is no pharmacist intervention, therefore, pack design and labelling are considered key elements to ensure the safe use of this type of medicines.
The information which should be included on the labelling and package leaflet is provided in Title V of Directive 2001/83/EC. In addition, the details on the display and readability of such information on the printed materials are included in the Guideline on the readability of the labelling and package leaflet of medicinal products for human use (Revision 1, 12 January 2009) (hereinafter “Readability guideline”). However, due to the different supply arrangements for non-prescription medicines across Europe, some of the principles of the presentation of the content of the labelling and package leaflet differ among Member States, in particular on the ones regarding the acceptability of symbols/pictograms and any additional information compatible with the Summary of Product Characteristics (SmPC).
A consultation with Member States on national practices regarding pack design and labelling for non-prescription medicines has taken place and this document summarises the basic recommendations/principles1 to guide applicants and marketing authorisation holders when preparing the mock-ups and specimens of the sales presentations2 of non-prescription medicines within the centralised procedure. It is acknowledged that national practices on pack design for non-prescription medicines differ across Member States, therefore, the recommendations included in this document should be considered in this context.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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FDA Publish Guidance on Safety Labeling Changes

Posted on April 25, 2011 by admin| Leave a comment

FDA Publish Guidance on Safety Labeling Changes

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This guidance provides information on the implementation of section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355(o)(4)) added by section 901 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 505(o)(4) authorizes FDA to require certain drug and biological product application holders to make safety related labeling changes based upon new safety information that becomes available after approval of the drug or biological product.
Section 505(o)(4) of the Act authorizes FDA to require safety labeling changes for the following products:
• prescription drug products with an approved new drug application (NDA) under section 505(b) of the Act
• biological drug products with an approved biologics license application (BLA) under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)
• prescription drug products with an approved abbreviated new drug application (ANDA) under section 505(j) of the Act, if the NDA reference listed drug (RLD) is not currently marketed
The section 505(o)(4) safety labeling changes provisions apply to the above-listed products, including products that are not marketed, unless approval of the NDA, BLA, or ANDA has been withdrawn in the Federal Register.

Section 505(o)(4) does not apply to nonprescription (over-the-counter) drugs approved under an NDA or to marketed unapproved drugs.2
This guidance does not address labeling supplements submitted voluntarily by an application holder. Application holders may submit labeling supplements for review at any time and without prior notification to FDA.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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FDA Publish Guidance on Communication of Safety Information.

Posted on November 29, 2010 by admin| Leave a comment

FDA Publish Guidance on Communication of Safety Information.

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This guidance provides recommendations to industry and FDA staff on the content and format of Dear Health Care Provider (DHCP) Letters. DHCP letters are correspondence ― usually in the form of a mass mailing from the manufacturer or distributor of a human drug or biologic, or from FDA ― intended to alert physicians and other health care providers responsible for patient care about important new information regarding a human drug or biologic (hereafter “drug” also refers to biologic and small molecule drug products). These recommendations are also intended to apply to DHCP letters distributed by electronic means (e.g., email) to the extent practical for the type of electronic communication used. This guidance provides recommendations on when to use a DHCP letter, the types of information to include in a DHCP letter, how to organize that information so that it is communicated effectively to health care practitioners, and formatting techniques to make the information more accessible.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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FDA Guidance – URLs on Electronic Product Labeling

Posted on November 10, 2010 by admin| Leave a comment

FDA Guidance – URLs on Electronic Product Labeling

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FDA is issuing this guidance document to recommend that manufacturers include their Uniform Resource Locator (URL) on their electronic product labels in addition to the requirements under 21 CFR 1010.3(a)(1) and (2) that manufacturers include their full name and address and place, month and year of manufacture on their electronic product identification tags or labels. FDA’s decision to encourage the addition of URLs on electronic products is a result of the recognition that URLs are now widely used in product identification. In addition, using a manufacturer’s website address enables the manufacturer to provide the manufacturer’s location and details that would not typically be included in a product tag or label, and allows the manufacturer to promptly update its address information whenever there is a change.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publishes, Guidance on centrally authorised products requiring a notification of a change for update of annexes

Posted on September 19, 2010 by admin| Leave a comment

EMA Publishes, Guidance on centrally authorised products requiring a notification of a change for update of annexes

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On 23 July 2010 and after a consultation phase, the EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any update of the annexes, except for those when the EMA has specifically indicated that a notification of a change is still required. The following table lists the centrally authorised products that the EMA requires to submit a notification of change before implementation due to safety or quality reasons.

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FDA Publishes Guidance on Organ-Specific Warnings: Internal Analgesic, Antipyretic and Antirheumatic Drug Products for Over the counter Human Use – Small Entity Compliance Guide

Posted on September 8, 2010 by admin| Leave a comment

FDA Publishes Guidance on Organ-Specific Warnings: Internal Analgesic, Antipyretic and Antirheumatic Drug Products for Over the counter Human Use – Small Entity Compliance Guide.

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This guidance is intended to help small businesses understand and comply with FDA’s organ-specific labeling regulation for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The regulation requires IAAA manufacturers to label their products with specific warnings and related information to alert consumers about potential liver injury and stomach bleeding associated with IAAA drug products. Manufacturers must be in compliance with the final rule beginning on April 29, 2010. The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Fairness Act (Public Law 104-121).

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FDA, Publish Guidance on Contact Lens Care Products Labeling

Posted on September 6, 2010 by admin| Leave a comment

FDA, Publish Guidance on Contact Lens Care Products Labeling

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This guidance document is an addendum to a special control guidance that supports the classification of the Contact Lens Care Products as class II (special controls). This draft guidance will be issued in conjunction with a Federal Register notice announcing the recommendations for labeling of contact lens care products.

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The MHRA, the UK drug Regulators, Published a Reminder – Update to Labelling to Comply with Article 54(a), 54(e) and 56(a)

Posted on July 26, 2010 by admin| Leave a comment

The MHRA, the UK drug Regulators, Published a Reminder – Update to Labelling to Comply with Article 54(a), 54(e) and 56(a).

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The legislation provided a transitional period for the labelling of medicines which were the subject of a granted marketing authorisation at the time the regulations came into force on 30 October 2005. This transitional period ends on 30th October 2010 by which time the necessary applications must have been approved to bring the marketing authorisations into compliance.
The new requirements for labelling under the articles cited above are as follows:
• Following the brand name of the medicine (where one has been registered) the packaging must include reference to the common name(s) of the active substances in the formulation (where up to three active substances are present in the formulation). The common name(s) must be prominently displayed on the packaging.
• Space for the prescribed dose to be indicated – in the UK this is in the form of space for a dispensing label to be indicated on the outer packaging. Such space should be 35mm by 70mm in size. Although not required by the legislation, best practice suggests that the space should be marked on the pack and appear on a face where the name of the medicine is displayed.
• The name registered in section 1 of the summary of product characteristics must be displayed in Braille on the packaging.
Detailed guidance on how to apply for these changes and the criteria which apply are available from the MHRA website.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators, FDA, Publiash Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages

Posted on April 4, 2010 by admin| Leave a comment

Drug Regulators, FDA, Publiash Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages

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This guidance is intended to address provisions set forth in Section 505D of the Federal Food, Drug, and Cosmetic Act (the Act) regarding development of standardized numerical identifiers (SNIs) for prescription drug packages. In this guidance, FDA is identifying package-level SNIs, as an initial step in FDA’s development and implementation of additional measures to secure the drug supply chain.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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Drug Regulators, FDA, Publish Guidance on An Acceptable Circular of Information for the Use of Human Blood and Blood Components

Posted on January 9, 2010 by admin| Leave a comment

Drug Regulators, FDA, Publish Guidance on An Acceptable Circular of Information for the Use of Human Blood and Blood Components

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The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, are recognizing as acceptable for use by you, manufacturers of blood and blood components intended for transfusion subject to United States statutes and regulations the instruction circular entitled “Circular of Information for the Use of Human Blood and Blood Components” (Circular) dated December 2009. The December 2009 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion. We believe that the Circular will assist you in complying with labeling requirements under 21 CFR 606.122 (§ 606.122). The requirements under § 606.122 specify that an instruction circular must be available for distribution with blood and blood components intended for transfusion. Section 606.122 further specifies the information that is required in the instruction circular. This guidance supersedes the guidance of the same title dated October 2009.

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Drug Regulators, FDA, CDER, Publish Guidance on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

Posted on December 29, 2009 by admin| Leave a comment

Drug Regulators, FDA, CDER, Publish Guidance on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

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This guidance describes how the Food and Drug Administration (FDA) reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO) instruments used to support claims in approved medical product labeling. A PRO instrument (i.e., a questionnaire plus the information and documentation that support its use) is a means to capture PRO data used to measure treatment benefit or risk in medical product clinical trials. This guidance does not address the use of PRO instruments for purposes beyond evaluation of claims made about a medical product in labeling. This guidance also does not address disease-specific issues. Guidance on clinical trial endpoints for specific diseases can be found on various FDA Web sites.
By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their discussions with the FDA during the medical product development process, streamline the FDA’s review of PRO instrument adequacy and resultant PRO data collected during a clinical trial, and provide optimal information about the patient perspective for use in making conclusions about treatment effect at the time of medical product approval. PRO instrument development is an iterative process and we recognize there is no single correct way to develop a PRO instrument. Different strategies and methods can be used to address FDA review issues.
The Glossary defines many of the terms used in this guidance. Words or phrases found in the Glossary appear in bold italics at first mention. Specifically, we encourage sponsors to familiarize themselves with the terms conceptual framework of a PRO instrument, endpoint model, and content validity.

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Drug Regulators, FDA, Publish Guidance on Dosage Delivery Devices for OTC Liquid Drug Products

Posted on December 4, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish Draft Guidance on Dosage Delivery Devices for OTC Liquid Drug Products

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This document is intended to provide guidance to firms that are manufacturing, marketing, or distributing over-the-counter (OTC) liquid drug products (e.g., elixirs, suspensions, solutions, syrups) that are packaged with dosage delivery devices (e.g., calibrated cups, droppers, syringes, spoons). Because written, printed, or graphic matter appearing on dosage delivery devices packaged with OTC liquid drug products is considered labeling, such markings on these devices must not be false or misleading and must be clear and consistent with the drug product’s directions for use. (See Sections 201(m), 502(a) and 502(f)(1) of the Federal Food, Drug, and  Cosmetic Act).

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

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Drug Regulators, FDA (CDER), Publishes Guidance on SPL Standard for Content of Labeling Technical Qs & As

Posted on November 23, 2009 by admin| Leave a comment

Drug Regulators, FDA (CDER), Publishes Guidance on SPL Standard for Content of Labeling Technical Qs & As

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This guidance is intended to assist applicants who submit content of labeling to FDA as part of a marketing application using the structured product labeling standard (SPL) in extensible markup language (XML). The guidance also provides information to FDA staff who review and manage product information using electronic systems. This is revision 1 of a guidance of the same name that was issued in December 2005. The guidance has been revised to reflect changes in the technology since 2005 and to harmonize the submission of SPL in the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). We anticipate that additional guidance will be provided as new questions arise about the use of SPL in different contexts.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

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FDA Publishes Guidance on Circular Information for the Use of Human Blood and Blood Components

Posted on November 13, 2009 by admin| Leave a comment

FDA Publishes Guidance on Circular Information for the Use of Human Blood and Blood Components

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The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, are recognizing as acceptable for use by, manufacturers of blood and blood components intended for transfusion subject to United States statutes and regulations the instruction circular entitled “Circular of Information for the Use of Human Blood and Blood Components” (Circular) dated August 2009. The August 2009 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion. We believe that the Circular will assist you in complying with labeling requirements under 21 CFR 606.122 (§ 606.122). The requirements under § 606.122 specify that an instruction circular must be available for distribution with blood and blood components intended for transfusion. Section 606.122 further specifies the information that is required in the instruction circular. This guidance supersedes the guidance of the same title dated December 2003.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

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Drug Regulators, FDA, Publish a Good Review Practice Guidance for Labeling for Human Prescription Drug and Biological Products

Posted on November 12, 2009 by admin| Leave a comment

Drug Regulators, FDA, Publish a Good Review Practice Guidance for Labeling for Human Prescription Drug and Biological Products

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This guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that describes the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling. Although not specifically required, the pharmacologic class can also appear in other sections of labeling. This guidance only applies to the use of the pharmacologic class in the Indications and Usage section of Highlights.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

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FDA Publishes New Guidance Page – Memoranda to Blood Establishments

Posted on October 31, 2009 by admin| Leave a comment

FDA Publishes New Web Guidance Page – Memoranda to Blood Establishments

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Blood memoranda have not been issued since January 1997. This information is now being issued as guidance documents.

The memoranda on this page are arranged in order by date, with the most recent memo added to the top of the list.

<p class=”MsoNormal”>If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com</p>

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Posted in biotechnology, clinical, formulation, labeling, manufacturing, pre-clinical, regulatory

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