Regulatory Roundup: FDA Provides Information on Advisory Committees, Announces Public Meetings, And More. - Pharmaceutical Technology

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Regulatory Roundup: FDA Provides Information on Advisory Committees, Announces Public Meetings, And More.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The FDA Transparency Blog now hosts a section about the agency’s advisory committees. The blog is part of the US Food and Drug Administration’s efforts to provide information about how the agency works to industry and the general public. The new section appears on the blog and on the FDA Basics web page and offers a Q&A about what advisory committees are, how members are selected, and how the committees contribute to larger FDA's decisions about drugs.

FDA will hold two public meetings taking place this September. The first meeting, taking place Sept. 17, in Rockville, Maryland, is meant to solicit stakeholder input on the development of a generic-drug user-fee program. According to the FDA announcement, “a user fee program could provide necessary supplemental funding, in addition to current Congressional appropriations, to allow for the timely review of such applications. Although the President’s Fiscal Year (FY) 2011 budget includes generic drug user fees, new legislation would be required for FDA to establish and collect user fees under such a program.”

The second hearing, taking place Sept. 27 and 28, in Silver Spring, Maryland, will address a new framework for the development and distribution of patient medication information for prescription products. The agency says that the current system of providing information to patients, which may include duplicates or be difficult to understand, needs to be revised. The agency is seeking input about the use of a single standardized document to include drug-product information.

Per its June 2010 guidance for industry on bioequivalence recommendations, FDA has updated its listing of individual product bioequivalence recommendations regarding active pharmaceutical ingredients. The updates include 26 new recommendations and 10 revised recommendations.

The agency also updated its adverse-event reporting system (AERS) database to include information from the second quarter of 2010 (i.e., from April to June). The database lists the names of products, potential signals of serious risks, and new safety information that was identified for the products during the review period. FDA posted the information as part of the 2007 Food and Drug Administration Amendments Act of 2007.


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