Advisory committees, FDA

Bigelow GE (1991) Draft Guidelines for Abuse Liability Assessment. Drug Abuse Advisory Committee, FDA, US Public Health Service... 

A. Wei, A. J. Grillo-Lopez, Rituximab Presentation to the US FDA Biologic Response Modifiers Advisory Committee, FDA Advisory Committee Meetings on Video Tape, F-D-C Reports, Special Projects Department (Phone 301-657-9830), July 25, 1997, http //www.fdaadvisorycommittee.com/ FDC/advisorycommittee/toc.htm. 

FDA initiated the adult antidepressant meta-analysis based on findings from a previous FDA meta-analysis of pediatric patients. In 2004, FDA completed a meta-analysis of pediatric patients that showed an association of antidepressant drugs and suicidal behavior and ideation (Hammad et al. 2006). Unsolicited information provided from drug sponsors and published articles motivated this meta-analysis. Based on the meta-analysis and deliberations from a meeting of FDA advisory committees, FDA added a boxed warning to the label of all antidepressants with the warning concerning pediatrics patients in 2005. The FDA advisory committees requested that FDA explore the association in adult patients. 

Sahcyhc acid USP, EP, and other pharmacopeia grades are used medically as antiseptic, disinfectant, antifungal, and keratolytic agents. Sahcyhc acid is formulated in lotion or ointment formulations for the treatment of dandmff, eczema, psoriasis, and various parasitic skin diseases. Because the keratolytic property of this aromatic acid has use in the safe removal of dead skin cells from the surface of healthy skin, the acid is used in concentrated sahcyhc acid solutions or suspensions to remove warts and corns. In more dilute form, sahcyhc acid preparations have found use in dandmff and eczema treatment. Sahcyhc acid has been considered and found effective by the Advisory Committees to the FDA in various over-the-counter (OTC) dmg regulated uses. Among these are acne products, dermatitis, dry skin, dandmff and psoriasis products, and foot care products (24). 

FDA, in its continuing attempts to promote the rational evolution of bioequivalency testing, sometimes appears to be caught between a rock and a hard place. Pharmaceutical scientists who have served on or testified before FDA Expert Advisory Committees, that have considered generic bioequivalency problems... 

The 1997 Food and Drug Administration Modernization Act (FDAMA) specifically recognizes the right of a licensed pharmacist to compound pharmaceutical products in response to, or in anticipation of an appropriate prescription. The Act also authorized the establishment of an FDA Expert Advisory Committee... 

Figure 4.12 The CDER review process for a typical NDA. In addition to the review stages described, the FDA may also consult with a technical advisory committee. The members of the advisory committee are not routinely involved in IND or NDA assessment. The FDA is not obliged to follow any advice given by the advisory committee, but it generally does so...

Food and Drug Administration Arthritis Advisory Committee, September 06,2005, Briefing Information, Bristol-Myers Squibb Company information [online]. Available at http //www. fda.gov/ohrms/ dockets/ac/05/briefing/2005-4170bl index%20with% 20disclaimer.htm... 

The Chairman of FDA s Advisory Committee commented on the risk of death from developing PPH. "We have had what 1 think appears to be a reasonable estimate of the risk of deaths from pulmonary hypertension. We need to understand clearly that if a million patients take this drug, at least a couple dozen of them will die annually as a result of this complication. That seems the best estimate. This is something that has to be weighed seriously." The appearance of heart valvulopathies in otherwise asymptomatic people in their thirties or forties was unexpected and caught patients and practitioners by surprise. Both fenfluramine and phentermine cause an increase in the amount of serotonin available in the body, which can cause cardiac valvulopathies. 

The FDA shall convene and consult an advisory committee on compounding that includes representatives from the National Association of Boards of Pharmacy, the United States Pharmacopeia, pharmacy, physician, and consumer organizations, and other selected experts. 

FDA s concerns regarding antibiotic resistance and the implications for human and animal health span some 30 years during which symposia, consultations with outside experts and task force reviews were held. Most notable among these actions was the establishment of the FDA Task Force on the Use of Antibiotics in Animal Feeds. Established in 1970 at the recommendation of FDA s Science Advisory Committee, the Task Force was asked to undertake a comprehensive review of the use of antibiotics in animal feeds. 

Provides for the use of scientific advisory committees to provide expert advice and recommendations to FDA regarding clinical investigation and approval of new drugs. 

Advisory committees. There is no statutory requirement that FDA review the approval of an NDA with an advisory committee before final action is taken. Since the 1970s, however, this has been the customary practice, particularly with important new drugs. This prompted Congress to enact a specific provision dealing with the establishment of drug advisory committees under the FDA Modernization Act of 1997. The review of an NDA by an advisory committee is an extremely important step in the approval process. It represents the best opportunity that the applicant has to address the agency and the public about the evidence of safety and effectiveness and the importance of the drug to public health. In the vast majority of cases, FDA accepts the recommendation of the advisory... 

FDA has also formed a Drug Safety and Risk Management Advisory Committee during this time, provided specific training for the members and has subsequently placed selected members on Advisory Committee Panels to consider various risks or to review existing risk management programs. 

FDA. 1996. Additional Market Review Information. Briefing Materials for Food Advisory Committee on Dietary Supplements Containing Ephedrine Alkaloids. Food and Drug Administration. Center for Food Safety and Applied Nutrition, USA. 35pp. 

Both of these elements are causing nervousness amongst regulators. So much so that, for example, the FDA Anti-Infective Drugs Advisory Committee (AIDAC) have recently recommended that the non-inferiority design should no longer... 

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