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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  19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 Next >>   FDA Releases Alexion Inspection Report [134 Words] [ Price : $7.95] FDA releases the FDA-483 detailing results of a 2012 inspection at an Alexion API facility that resulted in a Warning Letter. 04/10/2013     Court Ruling May Speed FOIA Responses [370 Words] [ Price : $7.95] Attorney Kurt Karst says a DC appeals court decision may help those seeking documents from FDA under the Freedom of Information Act to force the agency to move more quickly. 04/10/2013     Company Asks for Delay in Warning Letter Publication [175 Words] [ Price : $7.95] An unidentified company asks FDA not to publish a Warning Letter it received until the firm has exhausted its appeals and resolves other issues relating to contents of the letter. 04/10/2013     Some IVD Test Reviews Take Longer [135 Words] [ Price : $7.95] An Amplion Research report says that FDA review periods are lengthening for IVD tests using molecular biomarkers. 04/10/2013     FDA Budget Proposal Boosts Spending by 21% [982 Words] [ Price : $7.95] President Obama’s FY 2014 budget request boosts FDA’s spending to $4.7 billion, an increase of $821 million (21%) over FY 2012. 04/10/2013     Merck Gains ‘Breakthrough’ Status for Palbociclib [291 Words] [ Price : $7.95] FDA grants Pfizer a Breakthrough Therapy designation for palbociclib and its use in treating breast cancer. 04/10/2013     New Approaches Used to Optimize Protocol Design: Tufts [138 Words] [ Price : $7.95] Drug industry leaders say growing trial protocol complexity is leading to steps to optimize protocol design. 04/10/2013     Advisors Say Trulign Lens Safe, Effective [101 Words] [ Price : $7.95] Members of FDA’s Ophthalmic Devices Panel recommend to the agency that the Bausch & Lomb Trulign lens is safe and its benefits outweigh its risks. 04/09/2013     Some Accelerated Approval Drugs Face Market Withdrawal [1196 Words] [ Price : $7.95] CDER cancer drugs director Richard Pazdur, in a wide-ranging discussion with past and present advisory committee leaders, predicts that fast-track new drugs will continue to face market withdrawal, and cost-benefit will continue to not be an FDA approval factor. 04/09/2013     Von Eschenbach Pushes Device Industry Collaboration [228 Words] [ Price : $7.95] Former FDA commissioner Andrew von Eschenbach says today’s complex medical problems will only be solved if medical device companies collaborate with each other and share their intellectual property. 04/09/2013     << Prev  19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38  Next >>

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