Monthly Archives: September 2010

EMA Publishes, Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng, folium

Posted on September 16, 2010 by admin| Leave a comment

EMA Publishes, Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng, folium

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Arctostaphylos uva-ursi (L.) Spreng, folium (bearberry leaf)With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended Arctostaphylos uva-ursi (L.) Spreng, folium (bearberry leaf)
i) Herbal substance Whole or fragmented, dried leaf
ii) Herbal preparations
a) Comminuted herbal substance
b) Powdered herbal substance
c) Dry extract (DER 3.5-5.5:1), extraction solvent ethanol 60 % (V/V) quantified to 23.5-29.3% of hydroquinone derivatives calculated as anhydrous arbutin determined by spectrophotometry or corresponding amount of arbutin determined by HPLC
d) Dry extract (DER 2.5-4.5:1), extraction solvent water quantified to 20-28% of hydroquinone derivatives calculated as anhydrous arbutin determined by  spectrophotometry or corresponding amount of arbutin determined by HPLC

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EMA Announce, Tenth EMA Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting

Posted on September 16, 2010 by admin| Leave a comment

EMA Announce, Tenth EMA Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting

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The meeting covered the following topics: revision of the mandate and rules of procedure of the PCWP; the interaction between the Agency and health technology assessment bodies; the interaction between the Agency and patient & consumer organisations; direct reporting of adverse events by patients.

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NICE Publish Guidance on Adalimumab, etanercept, infliximab, rituximab and adataqcept for the treatment of rheumatoid arthritis after failure of a TNF Inhibitor

Posted on September 16, 2010 by admin| 1 Comment

NICE Publish Guidance on Adalimumab, etanercept, infliximab, rituximab and adataqcept for the treatment of rheumatoid arthritis after failure of a TNF Inhibitor.

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Rituximab in combination with methotrexate is recommended as an option for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to, or are intolerant of, other disease-modifying anti-rheumatic drugs (DMARDs), including at least one tumour necrosis factor (TNF) inhibitor. Treatment with rituximab should be given no more frequently than every 6 months.

Treatment with rituximab in combination with methotrexate should be continued only if there is an adequate response following initiation of therapy and if an adequate response is maintained following retreatment with a dosing interval of at least 6 months. An adequate response is defined as an improvement in disease activity score (DAS28) of 1.2 points or more.

Adalimumab, etanercept, infliximab and abatacept, each in combination with methotrexate, are recommended as treatment options only for adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab therapy because they have a contraindication to rituximab, or when rituximab is withdrawn because of an adverse event.

Adalimumab monotherapy and etanercept monotherapy are recommended as treatment options for adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab therapy because they have a contraindication to methotrexate, or when methotrexate is withdrawn because of an adverse event.

Treatment with adalimumab, etanercept, infliximab and abatacept should be continued only if there is an adequate response (as defined in 1.2) 6 months after initiation of therapy. Treatment should be monitored, with assessment of DAS28, at least every 6 months and continued only if an adequate response is maintained.

When using DAS28, healthcare professionals should take into account any physical, sensory or learning disabilities, communication difficulties, or disease characteristics that could adversely affect patient assessment and make any adjustments they consider appropriate.

A team experienced in the diagnosis and treatment of rheumatoid arthritis and working under the supervision of a rheumatologist should initiate, supervise and assess response to treatment with rituximab, adalimumab, etanercept, infliximab or abatacept.

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NICE Publishes Guidance on Etanercept, Infliximab and Adalimumab for the Treatment of Psoriatic Arthritis

Posted on September 15, 2010 by admin| Leave a comment

NICE Publishes Guidance on Etanercept, Infliximab and Adalimumab for the Treatment of Psoriatic Arthritis.

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Etanercept, infliximab and adalimumab are recommended for the treatment of adults with active and progressive psoriatic arthritis when the following criteria are met.

The person has peripheral arthritis with three or more tender joints and three or more swollen joints, and
The psoriatic arthritis has not responded to adequate trials of at least two standard disease-modifying antirheumatic drugs (DMARDs), administered either individually or in combination.

Treatment as described in 1.1 should normally be started with the least expensive drug (taking into account drug administration costs, required dose and product price per dose). This may need to be varied for individual patients because of differences in the method of administration and treatment schedules.

Etanercept, adalimumab or infliximab treatment should be discontinued in people whose psoriatic arthritis has not shown an adequate response using the Psoriatic Arthritis Response Criteria (PsARC) at 12 weeks. An adequate response is defined as an improvement in at least two of the four PsARC criteria, (one of which has to be joint tenderness or swelling score) with no worsening in any of the four criteria. People whose disease has a Psoriasis Area and Severity Index (PASI) 75 response at 12 weeks but whose PsARC response does not justify continuation of treatment should be assessed by a dermatologist to determine whether continuing treatment is appropriate on the basis of skin response (see ‘Etanercept and efalizumab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 103], ‘Infliximab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 134] and ‘Adalimumab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 146] for guidance on the use of tumour necrosis factor [TNF] inhibitors in psoriasis).

When using the PsARC healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect a person’s responses to components of the PsARC and make any adjustments they consider appropriate.

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EMA Announce First joint DIA/EMA workshop on statistical methodology in clinical R&D

Posted on September 15, 2010 by admin| Leave a comment

EMA Announce First joint DIA/EMA workshop on statistical methodology in clinical R&D

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This two and a half day event is the first joint Drug Information Association (DIA)/European Medicines Agency (EMA) workshop on statistical methodology in clinical research and development. In 2009, a biostatistics drafting group was established by the Agency comprising 10 statisticians from national competent authorities. This group and other Agency staff will contribute to the workshop and share expertise. Workshop participants will examine the ever important role of statistics in clinical R&D and will also discuss new ways of applying statistical methods.

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NICE Publish Guidance on Imatinib for the Adjutant Treatment of Gastrointestinal Stromal Tumours

Posted on September 14, 2010 by admin| Leave a comment

NICE Publish Guidance on Imatinib for the Adjutant Treatment of Gastrointestinal Stromal Tumours.

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Imatinib is not recommended for the adjuvant treatment of gastrointestinal stromal tumours (GISTs) after surgery. People currently receiving imatinib for the adjuvant treatment of gastrointestinal stromal tumours after surgery should have the option to continue treatment until they and their clinician consider it appropriate to stop.

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EMA Publishes, Assessment report on Cinnamomum verum J. S. Presl (Cinnamomum zeylanicum Nees), cortex and corticis aetheroleum

Posted on September 14, 2010 by admin| Leave a comment

EMA Publishes, Assessment report on Cinnamomum verum J. S. Presl (Cinnamomum zeylanicum Nees), cortex and corticis aetheroleum

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a) Comminuted herbal substance
b) Liquid extract (DER 1:1) extraction solvent: 70% ethanol
c) Tincture (ratio of herbal substance to extraction solvent 1:5) extraction solvent 70% ethanol
d) Essential oil obtained by steam distillation from the cortex

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EMA Publish List of references supporting the assessment of Cinnamomum verum J. S. Presl, (Cinnamomum zeylanicum Nees), cortex and corticis aetheroleum

Posted on September 14, 2010 by admin| Leave a comment

EMA Publish List of references supporting the assessment of Cinnamomum verum J. S. Presl, (Cinnamomum zeylanicum Nees), cortex and corticis aetheroleum

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The Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose.
References cited in the Assessment Report
Atta AH , Alkofahi A. Anti-nociceptive and anti-inflammatory effects of some Jordanian medicinal plant extracts . J. Ethnopharmacol. 1998, 60:117–24.
Barceloux DG. Cinnamon (Cinnamon Species). Dis. Mon. 2009, 55:327-55.
Barnes J, Anderson LA, Philipson JD. Herbal medicines. 3rd edition. Pharmaceutical press; 2007, 162-163.
Bisset NG. Cinnamomi cortex. In: Herbal drugs and phytopharmaceuticals. Medpharm Scientific Pulishers, Stuttgart; 1994, 148-150.
Buch JG, Dikshit RK, Mansuri SM. Effect of certain volatile oils on ejaculated human spermatozoa. Indian J. Med. Res. 1988, 87:361-63.
Cava R, Nowak E, Taboada A, Marin-Iniesta F. Antimicrobial activity of clove and cinnamon essential oils against Listeria monocytogenes in pasteurized milk. J. Food Prot. 2007, 70(12):2757-63.
Chen Y, Ma Y, Ma W. Pharmacokinetics and bioavailability of cinnamic acid after oral administration of ramumus cinnamoni in rats. Eur. J. Drug Metabolism and Pharmacokinetics 2009, 34:51-56.

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NICE Publish National Clinical Guideline for Diagnosis and Management of Chronic Heart Failure in Primary and Secondary Care

Posted on September 13, 2010 by admin| Leave a comment

NICE Publish National Clinical Guideline for Diagnosis and Management of Chronic Heart Failure in Primary and Secondary Care

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Heart failure is a complex clinical syndrome of symptoms and signs that suggest impairment of the heart as a pump supporting physiological circulation. It is caused by structural or functional abnormalities of the heart. The demonstration of objective evidence of these cardiac abnormalities is necessary for the diagnosis of heart failure to be made.
The symptoms most commonly encountered are breathlessness (exertional dyspnoea, orthopnoea and paroxysmal nocturnal dyspnoea) fatigue and ankle swelling.
Signs in heart failure could be due to pulmonary and systemic congestion, the structural abnormalities causing heart failure, the structural abnormalities resulting from heart failure, or from complications of therapy.
Initially, research into heart failure concentrated on patients with heart failure and reduced contraction of the left ventricle. Consequently, therapeutic interventions were tested in this group of patients. The agreed description of this group of patients is heart failure with left ventricular systolic dysfunction (LVSD).
Over the last 10 years it has become evident that almost half the patients with heart failure syndrome do not have LVSD. This group have had several definitions and names given to their condition. Since patients with LVSD are defined on the basis of their reduced left ventricular ejection fraction, the Guideline Development Group (GDG) elected to adopt the term heart failure with preserved ejection fraction (HFPEF) to describe patients with heart failure and no evidence of LVSD.
The GDG recognises that the two terms LVSD and HFPEF have several limitations. These include the variability of the left ventricular ejection fraction measured by different imaging modalities, and the lack of universal agreement on the threshold of ejection fraction at which LVSD and preserved ejection fraction are defined. Some assert that even in patients with HFPEF, there is an impairment of the contraction of the long axis of the left ventricle. Others claim that HFPEF is synonymous with diastolic heart failure. The latter is a controversial term. It does not have a universally accepted definition, it lacks an agreed detection method(s) and is challenged by those who believe it co-exists with an un-detected impairment of systolic function. Some authorities use the term heart failure with normal ejection fraction (HFNEF). Both HFNEF and HFPEF suffer similar limitations, and neither of them accurately describes an underlying unifying pathological feature beyond the absence of evident LVSD.
There is no single diagnostic test for heart failure, and diagnosis relies on clinical judgement based on a combination of history, physical examination and appropriate investigations. These are discussed in more detail in Chapter 4 – Diagnosing heart failure.

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EMA Pubish Community Herbal Monograph on Cinnamomum Verum J.S. Presl (Cinnamomum Zeylanicum Nees), Cortex

Posted on September 13, 2010 by admin| Leave a comment

EMA Publish Community Herbal Monograph on Cinnamomum Verum J.S. Presl (Cinnamomum Zeylanicum Nees), Cortex

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Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
The product is a traditional herbal medicinal product for use in a specified indication exclusively based upon long-standing use.

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NICE, Publish Guidance on Dronedarone for the Treatment of Non-Permanent Atrial Fibrillation

Posted on September 12, 2010 by admin| Leave a comment

NICE, Publish Guidance on Dronedarone for the Treatment of Non-Permanent Atrial Fibrillation

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Dronedarone is recommended as an option for the treatment of non-permanent atrial fibrillation only in people:
• whose atrial fibrillation is not controlled by first-line therapy (usually including beta-blockers), that is, as a second-line treatment option, and
• who have at least one of the following cardiovascular risk factors:
− hypertension requiring drugs of at least two different classes
− diabetes mellitus
− previous transient ischaemic attack, stroke or systemic embolism
− left atrial diameter of 50 mm or greater
− left ventricular ejection fraction less than 40% (noting that the summary of product characteristics [SPC] does not recommend dronedarone for people with left ventricular ejection fraction less than 35% because of limited experience of using it in this group) or
− age 70 years or older, and
• who do not have unstable New York Heart Association (NYHA) class III or IV heart failure.
People who do not meet the criteria in section 1.1 who are currently receiving dronedarone should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

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EMA Publish Community Herbal Monograph on Cinnamomum Verum J.S. Presl (Cinnamomum zeylanicum Nees), aetheroleum

Posted on September 12, 2010 by admin| Leave a comment

EMA Publish Community Herbal Monograph on Cinnamomum Verum J.S. Presl (Cinnamomum zeylanicum Nees), aetheroleum

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended. Cinnamomum verum J. S. Presl (Cinnamomum zeylanicum Nees), aetheroleum corticis (cinnamon bark oil)
i) Herbal substance Not applicable
ii) Herbal preparations
Essential oil obtained by steam distillation from the cortex

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FDA, Publish Guidance on Animal Studies for Cardiovascular Disease

Posted on September 11, 2010 by admin| Leave a comment

FDA, Publish Guidance on Animal Studies for Cardiovascular Disease.

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FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies involving cardiovascular devices, including intra-cardiac devices and devices used in the coronary and peripheral vasculature. The animal studies utilized for the assessment of these devices typically provide initial evidence of device safety, their potential performance when used in a living system, and the biologic response that a living system may mount towards the device. We recommend that members of industry and FDA staff who perform or review evaluations of animal studies for cardiovascular devices use this guidance. In this document, the terms “you” and “your” refer to members of industry, also known as “sponsors” or “applicants”. The terms “we,” “us,” “our,” and “Agency” refer to FDA.
The intent of this guidance is to provide a reference of best practices for the approach, conduct, and presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience, while accounting for modern animal care and use strategies. The guidance makes multiple references to pre-existing regulatory requirements involving animal care and use. Of note, FDA maintains a memorandum of understanding (MOU) with the U.S. Department of Agriculture (USDA) and the National Institutes of Health (NIH) that addresses common areas of regulatory practice under which animal studies are to be performed.
We recommend that you use this guidance to develop and present animal study protocols, methods, and reports that support the safety and performance of cardiovascular devices. We intend to use this guidance to review animal study protocols, methods, data, and reports provided in regulatory submissions to demonstrate the safety and performance of cardiovascular devices.

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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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DA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies involving cardiovascular devices, including intra-cardiac devices and devices used in the coronary and peripheral vasculature.

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EMA Publish List Of References Supporting the Assessment of Arctostaphylos uva-ursi (L.) Spreng, Folium

Posted on September 11, 2010 by admin| Leave a comment

EMA Publish List Of References Supporting the Assessment of Arctostaphylos uva-ursi (L.) Spreng, Folium

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The Agency acknowledges that copies of the underlying works used to produce this monograph were provided for research only with exclusion of any commercial purpose.
Adesunloye BA. Acute renal failure due to the herbal remedy CKLS. American Journal of Medicine 2003, 9343(03):00427-3.
Ahn KS, Moon K-Y, Lee J, Kim YS. Downregulation of NF-kappaB activation in human keratinocytes by melanogenic inhibitors. J Dermatol Sci 2003, 31(3):193-201.
Albrecht J, Kreyes G. Langzeitbehandlung von Dauerkatheterpatienten: Chemoprophylaxe oder Phytotherapie? Extracta urologica 1988, 11 5:277-80.
Alvarado F. The relationship between Na+ and the active transport of arbutin in the small intestine. Biochim. Biophys. Acta 1965, 109:478-94.
Alvarado F, Monreal J. Na+-Dependent active transport of phenylglucosides in the chicken small intestine. Comp.Biochem.Physiol 1967, 20:471-88.
Annuk H, Hirmo S, Türi E, Mikelsaar M, Arak E, Wadström T. Effect on cell surface hydrophobicity and susceptibility of Helicobacter pylori to medicinal plant extracts. FEMS Microbiol Lett 1999, 172:41-5.Assaf MH, Makboul MA, Beck JP, Anton R. Preliminary study of phenolic glycosides from Origanum
majorana; quantitative estimation of arbutin, cytotoxic activity of hydroquinone, Planta Medica 1987, 53(4):343-5.
Barnes J, Anderson L, Phillipson D. Herbal Medicines: A guide for healthcare professionals. 3rd ed. Pharmaceutical Press, London 2002, 577-9.

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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 Publishes Summary of Safety and Effectivenss Data (SSED) Clinical Section Checklist, office of device evaluation

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

FDA Publishes Summary of Safety and Effectiveness Data (SSED) Clinical Section Checklist, office of device evaluation.

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The Summary of Safety and Effectiveness (SSED) is a document mandated by the Food, Drug and Cosmetic Act subparagraph 520(h)(1)(A) to be publicly available upon issuance of an approval order of a premarket approval application (PMA). The SSED is applicable for all original PMAs and panel-track supplements.
It is an FDA document intended to present a reasoned, objective, and balanced summary of the scientific evidence, both positive and negative, that served as the basis of the decision to approve or deny the PMA.
There can be no claims in the SSED that are unsubstantiated by the clinical results of the PMA clinical study(ies). The SSED is not a marketing document, and should not contain marketing/advertising language.
NOTE: This checklist contains the essential elements that should, at minimum, be included in the clinical section of the SSED. Additional instructions or examples of what should be included under each topic heading are indicated by italicized text. This document is intended to provide general recommendations for writing the clinical portion of the SSED. However, there will be exceptions, as well as devices that will require additional sections.

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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 Community Herbal Monograph on Arctostaphylos uva-ursi (L.) Spreng, folium

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

EMA Publish Community Herbal Monograph on Arctostaphylos uva-ursi (L.) Spreng, folium

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With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended
Arctostaphylos uva-ursi (L.) Spreng, folium (bearberry leaf)

i) Herbal substance Whole or fragmented, dried leaf
ii) Herbal preparations
a) Comminuted herbal substance
b) Powdered herbal substance
c) Dry extract (DER 3.5-5.5:1), extraction solvent ethanol 60 % (V/V) quantified to 23.5-29.3% of hydroquinone derivatives calculated as anhydrous arbutin determined by spectrophotometry or corresponding amount of arbutin determined by HPLC
d) Dry extract (DER 2.5-4.5:1), extraction solvent water quantified to 20-28% of hydroquinone derivatives calculated as anhydrous arbutin determined by  spectrophotometry or corresponding amount of arbutin determined by HPLC

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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 Announces Grant Funding for Safety and Effectivenss of Orphan Products Rsearch Project Grant (R01)

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

FDA Announces Grant Funding for Safety and Effectiveness of Orphan Products Research Project Grant (R01)

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The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA’s Office of Orphan Products Development (OPD) grant program. The goal of FDA’s OPD grant  program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA  provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the  application’s Background and Significance section documentation to support the estimated prevalence of the orphan disease or condition (or in the case of a vaccine or diagnostic, information to support the  estimates of how many people will be administered the diagnostic or vaccine annually) and an explanation of how the proposed study will either help support product approval or provide essential data needed
for product development.

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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 Assessment Report on Arctostaphylos uva-ursi(L.) Spreng, Folium

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

EMA Publish Assessment Report on Arctostaphylos uva-ursi(L.) Spreng, Folium

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This draft Assessment Report is published to support the release for public consultation of the draft Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng, folium. It should be noted that this document is a working document, not yet fully edited, and which shall be further developed after the release for consultation of the monograph. Interested parties are welcome to submit comments to the HMPC secretariat, which the Rapporteur and the MLWP will take into consideration but no ‘overview of comments received during the public consultation’ will be prepared in relation to the comments that will be received on this draft assessment report. The publication of this draft assessment report has been agreed to facilitate the understanding by Interested Parties of the assessment that has been carried out so far and led to the preparation of the draft monograph.

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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 Announce Public Workshop, Optimizing Clinical Trial Deisngs for Pedatric Cardiovascaulr Devices

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

FDA Announce Public Workshop, Optimizing Clinical Trial Designs for Pediatric Cardiovascular Devices

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The Food and Drug Administration (FDA), with support from the American Academy of Pediatrics (AAP), the American College of Cardiology (ACC), Society for Cardiovascular Angiography and Interventions (SCAI), and the National Institutes of Health (NIH), is announcing a public Workshop on clinical trials for the development of pediatric cardiovascular devices.

Rarely have devices been developed, evaluated and approved specifically for treatment of children with congenital heart disease. The small, heterogeneous population, need for long-term follow-up, lack of market incentive, and misperceptions of regulatory requirements and costs are a few of the issues that make a standard randomized control trial difficult to conduct in pediatric cardiology. The purpose of the workshop is to solicit information from clinicians, academia, professional societies, other government agencies, and industry on various efficient and pragmatic clinical trial designs that are conducive to overcoming the challenges in developing devices for the pediatric cardiology patient population. The information gathered in this and future workshops will help to develop future guidance on optimal designs for pediatric cardiology device trials. The marketing approval of more cardiovascular devices specifically designed and/or labeled for pediatric patients would have a significant impact on public health.

Invited experts will address types of clinical trials with a particular focus on trial designs and statistical analysis methods, as well as alternative sources of clinical data, that can help to address the challenges in this particular patient population. After each section there will be an audience question and answer session and panel discussion allowing workshop participants to interact with the speakers and panelists. A concluding session will allow for additional interactions.

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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 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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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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