HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS

Welcome to FDAweb Pay Per View Search our 45,601 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Next >>   ‘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     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     << Prev  7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26  Next >>

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com