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Orthofix Petitions FDA Over Symbols in Device Labeling

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Orthofix petitions FDA requesting that it promptly enact a 4/2013 proposed rule on Use of Certain Symbols in Labeling to facilitat...

Residual Solvent PDE Recommendations

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Federal Register Notice: FDA makes draft recommendations available for new permitted daily exposure for two residual solvents.

Feds Issue Valeant Subpoenas Over Patient Assistance

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Valeant Pharmaceuticals says it recently received subpoenas from both the U.S. Attorneys Office for the District of Massachusetts ...

FDA Approves Boehringers Pradaxa Reversing Agent

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FDA grants accelerated approval for a Boehringer Ingelheim NDA for Praxbind (idarucizumab) for use in patients who are taking the ...

Guide on Shiga Toxin-Producing E. coli in Cattle

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FDA issues a final version of Guidance for Industry #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pat...

FDA Wants More Data on AstraZeneca Diabetes Drug Combo

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FDA issues AstraZeneca a complete response letter regarding its NDA for the investigational fixed-dose combination of saxagliptin ...

Partial Hold Ordered on Trial After Patient Death

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FDA places on partial clinical hold a Zafgen Phase 3 study of beloranib in Prader-Willi Syndrome, a rare genetic disorder with a h...

New Report Shows Improving Device Reviews at FDA

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The California Life Sciences Association reports recent improvements in medical device review performance at CDRH in an analysis o...

Sherman Returning to FDA to Work Under Califf

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FDA convinces former CDER Office of Medical Policy (OMP) director Rachel Sherman to return to the agency to serve as associate dep...

Public Meeting on Modernizing Biotechnology Products

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Federal Register Notice: FDA plans a public meeting 10/30 to discuss a presidential memorandum on modernizing the regulatory syste...