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New Regulatory Paradigm Needed for Communications with Doctors: PhRMA

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PhRMAs general counsel says FDA and industry need to revisit how the biopharmaceutical industry communicates with healthcare profe...

FDA, CMS Extend Parallel Review Pilot

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Federal Register Notice: FDA and the Centers for Medicare and Medicaid Services will extend a pilot program for an additional two ...

Versartis Gets Orphan Drug for Growth Hormone Deficiency

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FDA grants orphan drug designation to Versartis for its long-acting form of recombinant human growth hormone.

Mylan Acquires Respiratory Compound from Pfizer

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Mylan signs an agreement with Pfizer for worldwide rights to develop a novel long-acting muscarinic antagonist compound for variou...

Scientists Recommend Certain X-Rays for Protein Drug Development

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Scientists from two U.S. government national laboratories recommend using certain X-rays to speed investigations aimed at understa...

FDA, EMA Sharing Generic Drug Bioequivalence Info

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FDA says it is working with the European Medicines Agency and five European countries on joint inspections of bioequivalence studi...

CDER Updates NDA/BLA Filing Review Procedures

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An updated CDER internal policy outlines procedures for identifying review issues during the filing review of all original NDAs, B...

FDA Urging Electronic Submissions for Citizen Petitions

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FDA plans to update its administrative regulations in 21 CFR Part 10 to include an electronic method for citizen petition submissi...

Quality System Violations in Jacobus FDA-483

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FDA releases the inspection observations from a March-April inspection at Jacobus Pharmaceuticals.

FDA Approves Glaxos New COPD Drug

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FDA approves a GlaxoSmithKline NDA for Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term...