WASHINGTON (AP) -- The Food and Drug Administration announced proposed rules Thursday to reduce potential conflicts of interest among outside experts who advise the government on approval of drugs and other regulated products. The experts would have to disclose any financial ties to the industry under review. Experts on the advisory committees would have to fill out a form disclosing the potential conflicts and explaining why they should still be able to advise the agency. If the FDA agrees to a waiver, the disclosure form would be posted on the FDA's Web site, typically at least 15 days before the committee meets.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection on financial disclosure by clinical investigators.
The 1990s are regarded as one of the most positive decades for CME. This period saw rapid growth in professional organizations and a proliferation of research and publications. It also saw a spate of new regulation. The Accreditation Council for CME adopted the 1992 draft and used it as a basis for its Standards for Commercial Support, calling for disclosure of financial relationships and discussion of unapproved uses of drugs or medical devices. The final FDA guidelines of 1997 cleared up some of the doubt.
..., R-Iowa, called on the FDA to require financial disclosure in such petitions and asked Commissione...
...Staff: Financial Disclosure by Clinical Investigators; Availability...
... Court.Vermont law restricts the sale, disclosure, and use ofpharmacy records that reveal the prescr...S. 105,115 (1991) (content-based financial burden); MinneapolisStar & Tribune Co. v. Minnesot...
...PART 54: FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS. 54.5 - Agency evaluati...
The Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA advisory committee members, and FDA staff, entitled ``Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers.'' We are issuing the guidance to help the public, FDA advisory committee members, and FDA staff to understand the public availability of information regarding certain financial interests and waivers granted by FDA to permit individuals to participate in an advisory committee meeting. The guidance provides additional transparency to FDA's advisory committee process beyond current guidance. This guidance finalizes the draft guidance of the same title dated March 2010 an...
... 2002, FDA issued draft guidance on ``Disclosure of Conflicts of Interest for Special Government Em...
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