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Welcome to FDAweb Pay Per View Search our 45,601 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Next >>   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     Merck Gains ‘Breakthrough’ Status for Melanoma Therapy [140 Words] [ Price : $7.95] FDA grants Merck a breakthrough therapy designation for lambrolizumab (MK-3475) for treating patients with advanced melanoma. 04/24/2013     Law and Public Policy vs. Device Technology at FDLI [995 Words] [ Price : $7.95] Confronting private sector law and public policy arguments, CDRH associate director for international affairs Kimberly Trautman describes efforts to develop a single audit program for medical devices, acceptable across multiple jurisdictions. 04/24/2013     Hamburg ‘Enormously Troubled’ by FDA’s Fiscal Plight [726 Words] [ Price : $7.95] Keynoting the Food & Drug Law Institute’s 2013 annual conference, FDA commissioner Margaret Hamburg says she’s “enormously troubled” by the fact that “the agency’s responsibilities outstrip its resources” as a result of long-standing budgetary constraints. 04/24/2013     Device Problem Reporting — There’s an App for That [152 Words] [ Price : $7.95] FDA releases its MedWatcher mobile app for reporting medical device problems. 04/24/2013     Guidance on Safety Considerations for Container Labeling [101 Words] [ Price : $7.95] Federal Register Notice: FDA releases a draft guidance, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. 04/24/2013     Recent Court Decisions Open Door to More State Liability Suits: WLF [340 Words] [ Price : $7.95] A Washington Legal Foundation paper examines recent First Amendment-related court decisions that have opened the door to increased state tort product liability lawsuits. 04/24/2013     FDA Clears Liposuction Fat Harvesting for Fat Grafting [101 Words] [ Price : $7.95] FDA clears an Andrew Technologies 510(k) for its Autologous Fat Transfer procedure that reinjects adipose tissue (fat) harvested during a HydraSolve liposuction procedure into the same patient for rejuvenation or augmentation. 04/24/2013     Feds Sue Novartis Over False Claims Act Violations [569 Words] [ Price : $7.95] The U.S. government files suit against Novartis for False Claims Act violations involving the transplant drug Myfortic. 04/24/2013     << Prev  6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25  Next >>

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