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FDA Issues Draft Guidance on User-Fee Waivers, Reductions, and Refunds
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| By
Angie Drakulich
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FDA issued a draft guidance for industry on Mar. 11, 2011, titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants seeking such actions under the Federal Food, Drug, & Cosmetic Act (FD&C Act). A similar draft guidance was issued in July 1993. The new document clarifies the types of waivers, refunds, and reductions available under the user-fee provisions of the FD&C Act as well as the procedures for handling these requests, including how to appeal an FDA decision.
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Senate Passes Patent-Reform Bill
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| By
Erik Greb
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Last Tuesday, the US Senate approved the "America Invents Act," which is intended to reform the nation ’s patent system. If it becomes law, the bill will establish a first-to-file system by defining an invention ’s effective filing date as the actual filing date of the patent or patent application.
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FDA Files Consent Decree against Johnson & Johnson
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| By
Erik Greb
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Last Thursday, FDA filed a consent decree of permanent injunction against McNeil, a subsidiary of Johnson & Johnson, for failing to comply with current good manufacturing practice requirements. The action prevents McNeil from manufacturing and distributing drugs from its Fort Washington, Pennsylvania, facility until FDA determines that its operations comply with the law.
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SOCMA and EFCG Urge for Reform in FDA Inspections of Foreign Drug-Manufacturing Facilities
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| By
Patricia Van Arnum
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The Bulk Pharmaceutical Task Force (BPTF) of the Society for Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) of the European Chemical Industry Council (CEFIC) are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient (API) manufacturing sites with the cost borne by those sites being inspected. Both organizations have indicated a willingness to pay fees for these inspections when performed on their member-owned facilities that are located outside the United States.
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Week of Mar. 14, 2011: Company and People Notes: Epizyme signs drug-development deal with Eisai; Greg Plowman Joins Eli Lilly; and More.
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Epizyme signs drug-development deal with Eisai; Greg Plowman Joins Eli Lilly; and More.
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Regulatory Roundup: FDA and EMA Announce Joint Pilot Program
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FDA and EMA Announce Joint Pilot Program
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