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A year after the event, FDA now says a Custom Medical Specialties recall of 14 types of surgical kits was Class 1.[ Price : $8.95]
FDA awards Vince & Associates a five-year contract for research on bioequivalence of branded and generic drugs.[ Price : $8.95]
FDA forms an internal task force to help sponsors develop new antibacterial drugs.[ Price : $8.95]
Peregrine Pharmaceuticals says it discovered major discrepancies with data coming from a Phase 2 trial of bavituximab in second-li...[ Price : $8.95]
FDA says ICH guidances offered on stabilty data required for reviewing NDAs also applies to ANDAs.[ Price : $8.95]
An FDA compliance consultant says companies responding to FDA-483s on systemic corrections should provide a well-documented plan f...[ Price : $8.95]
Federal Register Notice: FDA asks patient stakeholders to notify the agency of their intent to participate in meetings on drug dev...[ Price : $8.95]
Federal Register Notice: FDA announces a public meeting 10/25 on the agencys patient-focused drug development initiative.