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Two Project on Government Oversight reports call for an end to user fees that the group says make FDA too financially dependent on...[ Price : $8.95]
Egalet Corp. files a supplemental NDA for Oxaydo (oxycodone HCl) tablets for an abuse-deterrent label claim for the intravenous ro...[ Price : $8.95]
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FDA denies two petitions asking it to find that Wyeths original formulation of Protonix IV was not withdrawn for reasons of safety...[ Price : $8.95]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...