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"Guidance for Industry
"Fast Track Drug Development Programs – Designation, Development, and Application Review
"Introduction
The fast track programs of the Food and Drug Administration (FDA) are designed to
facilitate the development and expedite the review of new drugs that are intended
to treat serious or life-threatening conditions and that demonstrate the potential
to address unmet medical needs (fast track products).
This document provides guidance to industry on the regulations, policies, and procedures related to the Agency's fast track programs. The guidance also clarifies the criteria and processes for designating fast track products."This guidance revises the Fast Track guidance that published September 1998.
The revision is intended to make it clear that a drug can be said to address an unmet medical need if the only available treatments for the condition are approved under the accelerated approval regulations (21 CFR. 314.500 and 601.40), either on the basis of an effect on a surrogate endpoint or with restrictions on distribution.
Minor editorial changes also have been made to make this guidance consistent with the Agency's good guidance practices (GGP) regulation (21 CFR 10.115).
"FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required."
"Overview and General Information on Advisory Committee Membership
"What is an FDA Advisory Committee?
"Advisory committees provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, biological products, medical devices, and food. In general, advisory committees include a Chair, several members, plus a consumer, industry and sometimes a patient representative.
Additional experts with special knowledge may be added for individual meetings as needed.
Although the committees provide advice to the Agency, final decisions are made by FDA.
"How does an individual become a member of an FDA advisory committee?
"Nominations for scientific members, consumer, industry and patient representatives originate from professional societies, industry, consumer and patient advocacy groups, the individual himself or other interested persons.
"Candidates are asked to provide detailed information regarding financial holdings, employment, research grants and contracts, and other potential conflicts of interest that may preclude membership.
"What are the qualifications of an advisory committee member?
"Persons nominated as scientific members must be technically qualified experts in their field (e.g., clinical medicine, engineering, biological and physical sciences, biostatistics, and food sciences) and have experience interpreting complex data.
Candidates must be able to analyze detailed scientific data and understand its public health significance." fda.gov/cder/audiences
"Peripheral & Central Nervous System Drugs Advisory Committee Charter
"Function
"The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of neurologic diseases and makes appropriate recommendations to the Commissioner of Food and Drugs.
"Structure
"The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties.
The core of voting members may include one technically qualified member, selected
by the Commissioner or designee, who is identified with consumer interests and is
recommended by either a consortium of consumer-
In addition to the voting members, the Committee may include one non-
"The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees (normally not to exceed 10 members) to serve temporarily as voting members and to designate consultants to serve temporarily as voting members when:
(1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, a quorum will be based on the combined total of regular and added members).
(2) to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking."
