Tag Archive
The following is a list of all entries tagged with FDA:
EMA and FDA Seek Candidate for Joint GMP Inspection Programme
Filed in manufacturing, September 2, 2010, 10:26 amThe European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products
The FDA, Issues Assessments of the 510(k) Programme and Use of Science in Decision-Making
Filed in devices, September 1, 2010, 10:25 amThe U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety
FDA, the US Drug Regulator, Reminder of Tropical Disease Priority Review Vouchers
Filed in Fund raising,regulatory, July 15, 2010, 9:02 amA priority review voucher may be used by the sponsor who obtains it or another sponsor to obtain a priority review for a different application. A priority review voucher may be transferred from the sponsor who obtains it to another sponsor.
Drug Regulators, FDA, Publish Guidance for Public, FDA Advisory Committee Members and FDA Staff, on Public Availability of Advisory Committee Members Financial Interest Information and Waivers
Filed in business,regulatory, May 23, 2010, 8:17 amThis guidance is intended to help the public, Food and Drug Administration (FDA) advisory committee members, and FDA staff to understand and implement statutory requirements and FDA policy regarding public availability of information about financial interests and waivers granted by FDA to permit individuals to participate in advisory committee meetings subject to the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2).
Regulators Publish Guidance for Industry, Non Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization.
Filed in pre-clinical, January 26, 2010, 10:07 amThe purpose of this document is to recommend international standards for, and promote harmonization of, the nonclinical safety studies recommended to support human clinical trials of a given scope and duration as well as marketing authorization for pharmaceuticals. Harmonization of the guidance for nonclinical safety studies will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.
Drug Regulators, FDA CDER, Publish Guidance to Pharmacies on Compounding Oral Suspension
Filed in manufacturing,marketing, January 24, 2010, 10:04 amThis guidance provides recommendations to pharmacies on the advance compounding of Tamilfu oral suspension to provide multiple prescriptions. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.
Drug Regulators, FDA, Publish Guidance on An Acceptable Circular of Information for the Use of Human Blood and Blood Components
Filed in labeling,manufacturing, January 9, 2010, 8:39 amThe 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
Drug Regulators, FDA, Publishes Guidance on Pharmaceutical Development Q8(R2)
Filed in manufacturing,regulatory, December 25, 2009, 8:26 amThe Q8 parent guidance describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format.
Drug Regulators FDA, Publish Draft Guidance on the Assessment of Blood Donor Suitability, Product Safety and Preservation of the Blood Supply in Response to H1N1 pandemic
Filed in manufacturing, December 16, 2009, 11:29 amThis guidance document provides recommendations for assessing blood donor suitability and blood product safety and maintaining blood and blood product availability in response to pandemic (H1N1) 2009 virus. It is intended for establishments that manufacture Whole Blood and blood components intended for use in transfusion and blood components intended for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes.
FDA Convenes Meeting Regarding Online Advertising
Filed in business,marketing,regulatory, December 12, 2009, 8:59 amAt a two-day meeting convened Thursday by the FDA, representatives from the pharmaceutical and other industries are gathering to give their opinions on how the US regulator should regulate advertising for drug products through the Internet and social media. The FDA agreed to consider formulating guidelines for online advertisements based on companies’ concerns that regulations for traditional media, particularly those involving the disclosure of side effects, may not be appropriate for the Internet.
Drug Regulators, FDA, Publish Guidance on Dosage Delivery Devices for OTC Liquid Drug Products
Filed in labeling,manufacturing,marketing, December 4, 2009, 11:11 amThis 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).
Drug Regulators, FDA CDER, Publish Updated Guidance on Investigator Responsibilities for Study Subjects
Filed in clinical, November 24, 2009, 5:19 pmThis guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)).
Drug Regulators, FDA (CDER), Publishes Guidance on SPL Standard for Content of Labeling Technical Qs & As
Filed in labeling,marketing,regulatory, November 23, 2009, 12:43 pmThis 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)
Liver Toxicity, FDA DILI Regulations Require Interpretation
Filed in clinical,pre-clinical,report, November 20, 2009, 5:15 pmSigns of liver toxicity from experimental results can mean that a project is killed or investors walk away, but this is often an inappropriate response. Liver toxicity is a highly complex issue and in an attempt to provide some light on the issue the FDA has recently published guidelines on Drug Induced Liver Injury (DILI). These guidelines set the regulatory standard and take a very pragmatic position on livertox and encourage industry to likewise take a pragmatic view.
Drug Regulators, FDA, Publish Guidance for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoiteic Reconstitution for Specific Indications
Filed in licensing,manufacturing,marketing, November 16, 2009, 4:18 pmThe Center for Biologics Evaluation and Research (CBER), FDA, are recommending ways that would allow the manufacturer, generally a cord blood bank, to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for specified indications.
Drug Regulators, FDA, Publish Draft Guidance on IND’s for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood
Filed in regulatory, November 14, 2009, 4:06 pmThe Center for Biologics Evaluation and Research (CBER), FDA, are providing advice to potential sponsors (e.g., generally cord blood banks, or registries, and individual physicians serving as sponsor-investigators) to assist in the submission of an investigational new drug application (IND) for certain hematopoietic progenitor cells, cord (HPC-C)
FDA Publishes Guidance on Circular Information for the Use of Human Blood and Blood Components
Filed in labeling,regulatory, November 13, 2009, 4:02 pmThe August 2009 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion
Drug Regulators, FDA, Publish a Good Review Practice Guidance for Labeling for Human Prescription Drug and Biological Products
Filed in labeling,regulatory, November 12, 2009, 3:57 pmThis 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
FDA Publishes New Guidance Page – Memoranda to Blood Establishments
Filed in biotechnology,clinical,formulation,labeling,manufacturing,pre-clinical,regulatory, October 31, 2009, 12:10 pmBlood memoranda have not been issued since January 1997. This information is now being issued as guidance documents.
Drug Regulators Publish Guidance for Allogenic Pancreatic Islet Cell Products
Filed in Uncategorized,clinical,manufacturing,pre-clinical,regulatory, October 30, 2009, 11:13 amThis guidance provides recommendations to manufacturers, sponsors, and clinical investigators involved in the clinical studies of allogeneic pancreatic islet cell products for the treatment of Type 1 diabetes mellitus
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