Pharmacologic Drugs Advisory

Anello C. Adverse behavior reactions attributed to triazolam in the FDA s Spontaneous Reporting System. Presented at the Pharmacological Drugs Advisory Committee Meeting, Washington, DC, September 1989. 

The FDA s Pharmacologic Drugs Advisory Committee met a second time on January 31, 1985, to discuss TD. Leber again mentioned the impact of the clamor from the press in the fall of 1983—the date of Dan Rather s TV report and the simultaneous publication of my book. 

Sertindole is not currently approved in the USA in April 2009 the FDA Psycho-pharmacologic Drugs Advisory Committee voted 13-0 when asked if sertindole had been shown to be effective in the treatment of schizophrenia, but 12-1 when asked if it had shown to be acceptably safe [146 ]. 

There are a number of critical elements in an efficient university clinical pharmacology department. They include teaching, analytical and experimental laboratory work, clinical service, drug information and critical appraisal, advisory support for the professions, drug safety research and evaluation, and pharmacovigilance. 

Food and Drug Administration Advisory Committee for pharmaceutical sciences and Clinical Pharmacology Subcommittee meeting. Issues and challenges in the evaluation and labeling of drug interaction potentials of NME. Rockville, MD, April 23, 2003 http //www.fda.gov/ohrms/dockets/ac/03/ slides/3947s2.htm http //www.fda.gov/ohrms/dockets/ac/03/transcripts /... 

The Medicines Assessment Advisory Committee (MAAC) was established in 1984 under the provisions of section 8 of the Medicines Act 1981 as an advisory committee to the Minister of Health. Prior to 1984 the Drug Assessment Advisory Committee operated under the provisions of the now-repealed Food and Drug Act 1969. The MAAC is made up of experts in various fields of medicine, clinical pharmacology, toxicology, statistics and pharmaceutical chemistry. The MAAC and its subcommittees currently include a total of 16 members, some of whom serve as core members and some as pool members. Core members attend all meetings of the committee, whereas pool members attend only those meetings for which they have conducted assessments of applications within their areas of expertise. The MAAC meets four times a year. 

SOURCE Kaitin et al., FDA Advisory Committees and the New Drug Approval Process, Journal of Clinical Pharmacology 29 888-890, 1989. 

In order to structure the decision making process around the positive list efficiently, a formal advisory committee can be established. It should consist of medical and pharmaceutical experts, and have ready access to internationally recognized experts in the held of clinical pharmacology who can be consulted when necessary. This committee will on request provide advice as to whether particular products meet the criteria for reimbursement. The committee may also be accorded the task of periodically revising the drug list and make proposals for delehng obsolete items. 

---