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Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduce a bill to reduce red tape at FDA and boost innovation in health in...[ Price : $8.95]
A Wiley Rein client alert opines on a recent draft guidance offering generic drug sponsors one means to get testing samples from r...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: entitled How to Obtain a Letter from FDA Stating that Bioequivalence Study...[ Price : $8.95]
Federal Register Notice: FDA withdraws approval of 23 NDAs and 68 ANDAs that are no longer marketed.[ Price : $8.95]
FDA approves a Wraser Pharmaceuticals NDA for Trezix (acetaminophen/caffeine/dihydrocodeine bitartrate) capsules, indicated for pa...[ Price : $8.95]
FDA issues fewer FDA-483s in fiscal year 2014 than last year, according to just-released inspection data.[ Price : $8.95]
Main Street Family Pharmacy (Newbern, TN) and co-owner David A. Newbaker plead guilty in Western Tennessee District Court to one m...[ Price : $8.95]
Atossa Genetics says it has received inspection close-out notifications for FDA inspections conducted in 2012 and 2014.