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CDER issues its latest drug standards program quarterly progress report.[ Price : $8.95]
FDA denies two petitions asking it to find that Wyeths original formulation of Protonix IV was not withdrawn for reasons of safety...[ Price : $8.95]
Pfizer says its pivotal REFLECTIONS B3271002 study, a comparative safety and efficacy study of biosimilar candidate PF-05280014 ve...[ Price : $8.95]
FDA sets a user fee review goal date of 7/7/2017 for an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade ...[ Price : $8.95]
FDA deputy commissioner Howard Sklamberg outlines a new final rule with data submission requirements for importers of FDA-regulate...[ Price : $8.95]
FDA cites Prescription Lab Compounding Pharmacy and Stonegate Pharmacy in two recent Warning Letters as part of FDAs increased scr...[ Price : $8.95]
A day before the House passes it, a key committee denies a request by Rep. Louise Slaughter (D-NY) to add an amendment to the 21st...[ Price : $8.95]
Adapt Pharma Operations asks FDA not to approve ANDA for generic forms of Narcan until the agency has evaluated and implemented ph...