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Welcome to FDAweb Pay Per View Search our 45,629 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Next >>   AMA Wants Opioid Use Petition Rejected [324 Words] [ Price : $7.95] The American Medical Association calls on FDA to reject a petition asking for changes in opioid analgesic labeling to restrict its use. 04/25/2013     FDA Agrees to PMA Module for Cerus Blood System [119 Words] [ Price : $7.95] FDA agrees to a Cerus Corp. plan to submit a modular PMA for its Intercept Blood System for platelets. 04/25/2013     Will Other Companies Seek OxyContin-like Generics Safety Ban? [502 Words] [ Price : $7.95] Attorneys say it is likely that some branded drug companies will seek to withdraw non-abuse-deterrent products for reasons of safety as a means of blocking generic competition. 04/25/2013     Panel to Discuss SpinalMotion PMAs for Disc Replacement [200 Words] [ Price : $7.95] Federal Register Notice: FDA’s Orthopedic and Rehabilitation Devices Panel will meet 7/24-25 to discuss two SpinalMotion PMAs for the Kineflex/C-Cervical Artifical Disc and the Kineflex Lumbar Artifical Disc. 04/25/2013     Assay Migration Study Guidance Out [160 Words] [ Price : $7.95] CDRH releases a guidance on study designs and performance criteria for sponsors to use when a diagnostic assay is migrating to another system. 04/24/2013     ‘Amazing’ Response to ‘Breakthrough’ Designations: Woodcock [954 Words] [ Price : $7.95] CDER director Janet Woodcock tells FDLI she’s amazed by industry’s enthusiastic response to her Center’s new breakthrough therapy designations program authorized by FDASIA legislation. 04/24/2013     Courts Boost 1st Amendment Defense in Off-label Cases [884 Words] [ Price : $7.95] Legal experts review a series of court rulings that offer greater latitude for constructing First Amendment defense against allegations of unlawful off-label promotions. 04/24/2013     FDA, Partners Identifying Counterfeit Anti-malarials [374 Words] [ Price : $7.95] FDA says it is partnering with a number of organizations to test an agency-developed handheld device that may detect counterfeit and substandard anti-malarial drugs. 04/24/2013     Actelion Wants Generic Ventavis Standards [278 Words] [ Price : $7.95] Actelion asks FDA to apply standards and conditions to any ANDA referencing its Ventavis inhalation solution. 04/24/2013     FDA Conducts ‘Unprecedented’ 17 Joint Inspections Abroad [484 Words] [ Price : $7.95] Acting associate commissioner for regulatory affairs Melinda Plaisir says FDA is rapidly moving to more reliance of foreign regulatory partners with, so far, 17 joint inspections ─ “an unprecedented step.” 04/24/2013     << Prev  9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28  Next >>

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