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FDA Approves Cialis Label Addition

[ Price : $8.95]

FDA approves an Eli Lilly product label addition for Cialis (tadalafil) to include data from a 26-week study that showed Cialis 5 ...

CDER, Duke Plan Investigator Training

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Federal Register Notice: CDERs Office of Medical Policy and Duke University plan a training course for clinical investigators 11/1...

Animal Drug Regs Reflect July Approvals

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Federal Register Final rule: FDA amends the animal drug regulations to reflect July approval actions and also to reflect a sponsor...

Panel Backs Gileads Sofosbuvir for Hepatitis C

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An FDA advisory committee votes (15 to 0) to recommend approval of Gileads sofosbuvir to be used in combination with other agents ...

FDA Approves GE Healthcares Vizamyl

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FDA approves GE Healthcares Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission to...

FDA Backs Stricter Controls for Hydrocodone Combination Products

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FDA decides to recommend that hydrocodone combination products, such as Vicodin, be reclassified from Schedule III to Schedule II.

FDA Seeks Help in Tobacco Committee Selection

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Federal Register Notice: FDA seeks participants interested in helping to select nonvoting industry representatives on the Tobacco ...

GPhA Asks Many Questions About Stability Guidance

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The Generic Pharmaceutical Association asks FDA many questions about its draft guidance on stability testing for ANDAs.

CDER Opens Web Page for IND Investigators

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CDER launches a Web navigational tool for academic investigators working on IND applications.

Comments Sought on Therapeutic Area Standards Plan

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FDA releases for comment the Therapeutic Area Standards project plan for PDUFA 5 drug and biologic clinical terminology standards....