Oct. 1, 2012 | Vol. 11 No. 192 | Full Issue in PDF Format
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The FDA is considering elevating staff that deals with drug shortages from the Office of New Drugs to the Office of the Center Director, the agency says.
Endo Pharmaceuticals is petitioning the FDA to require generics referencing its crush-resistant pain drug, Opana ER CRF, demonstrate they are similarly crush-resistant.
An Indian panel of government ministers has recommended price controls be applied to all 348 generic drugs on the country’s essential generic drug list.
Drugmakers should use superiority trials when developing antimicrobial drugs for the treatment of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), according to an updated agency guidance.
FDA Draft Guidance Suggests Primary Endpoint for Clinical Trials of Complicated Abdominal Infections
Clinical trials of drugs to treat complicated intra-abdominal infections (cIAI) should have a primary endpoint of complete resolution of symptoms at 28 days following randomization and the absence of clinical failure, according to an FDA draft guidance.
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