What is the purpose of an FDA advisory committee?

What is the purpose of an FDA advisory committee?

Advisory committees provide independent advice and recommendations to the Food and Drug Administration (FDA) on scientific and technical matters related to the development and evaluation of products regulated by the Agency.

What role does the advisory committee serve in the NDA BLA review process?

The primary purpose of FDA advisory committees, as stated in the NDA Rewrite, is to assist the agency in making “sound decisions based upon the reasoned application of good science.” They do so by advising on the approvability of specific product applications based on an examination of the adequacy of the data …

What are the responsibilities of an advisory board?

The function of an advisory board is to offer assistance to enterprises with anything from marketing to managing human resources to influencing the direction of regulators. Advisory boards are composed of accomplished experts offering innovative advice and dynamic perspectives.

What is an Adcom meeting?

During an ADCOM meeting, an independent panel evaluates the benefits and risks of the product. The FDA poses one or more questions to the panel, including whether the product should be approved, and the meeting culminates with a vote on each question.

How often do advisory boards meet?

Dealing with advisory boards may be less time-consuming than dealing with boards of directors. The latter will typically meet at least four times a year, often more frequently; board committee meetings require additional time. A typical advisory board will meet only once or twice a year.

How do I prepare for a FDA meeting?

Outline and rehearse contingency plans. Consider the need for a formal presentation. Critically evaluate preliminary feedback from the FDA and the implications for your program. Prepare follow-up discussion points, questions, and “fallback positions” on key questions at the meeting.

What are the functions of an FDA Advisory Committee?

Advisory Committees FDA’s advisory committees are established to provide functions which support the agency’s mission of protecting and promoting the public health, while meeting the requirements set forth in the Federal Advisory Committee Act.

Who are the members of the Food and Drug Committee?

The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner of Food and Drugs. The Committee shall consist of a core of 13 voting members including the Chair.

What does the oncologic drugs advisory committee do?

Meeting materials from 2015 and older are archived. The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner of Food and Drugs.