FDA Advisory Committee Meeting
The FDA Advisory Committee Meeting ( AdCom ) refers to the meeting of a committee of independent experts that the Food and Drug Administration (FDA), the American health authority, in its decision on the approval of human and veterinary drugs , vaccinations and other biological products at the end of the approval process advisory support.
introduction
In the early 1960s, the FDA began convening advisory committees to evaluate new drugs and assist the FDA in deciding whether to approve or reject new drugs. In particular, due to key events such as the occurrence of serious side effects of drugs (e.g. thalidomide ) or amendments to the `` Federal Food, Drug, and Cosmetic Act '' (1962), drug manufacturers were asked to ensure the safety and reliability of their Product.
Current situation
The FDA is required to weigh different requirements from stakeholders (e.g. industry, patients) in their decision to approve or refuse a drug for use. An independent body of external experts such as B. Industry representatives or patient representatives helps to make a decision in favor of or against the approval of a new drug in a public meeting. More than 40 committees are available to advise the authority. Although the decision of the committee is not binding on the FDA, it still largely follows the decision of this panel of experts.
Procedure for an advisory committee meeting
The manufacturer of a new drug will be informed of the date by the FDA 90 days before the scheduled AdCom meeting. Usually, however, the sponsor's preparation begins much earlier, with the processes and the best possible presentation being practiced in trial runs.
The publicly accessible meeting itself usually consists of a 60-90 minute presentation by the manufacturer and a presentation by the FDA itself. Comments can then be submitted by the public and questions can be asked. Finally, the committee gives an assessment of the safety, efficiency and approval of the product. The FDA followed approximately 87% of the recommendations made by the advisory committee meetings that were convened.
Individual evidence
- ↑ What is an FDA Advisory Committee? FDA, accessed February 10, 2016 .
- ↑ a b c d e FDA Advisory Committee Meetings: What they are, why they happen, and what they mean for regulatory professionals. (pdf) Topra, accessed on February 10, 2016 (English).