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Federal Register Notice: FDA seeks information on appropriate uses of the custom device exemption under the Food and Drug Administ...[ Price : $8.95]
A final ICH guidance on Q11 Development and Manufacture of Drug Substances describes approaches to developing and understanding th...[ Price : $8.95]
A federal judge dismisses a former Pfizer employee's whistleblower suit alleging that the company illegally promoted its cholester...[ Price : $8.95]
FDA approves Dexcoms continuous glucose monitoring system, the Dexcom G4 PLATINUM.[ Price : $8.95]
PolyMedix receives guidance in a meeting with FDA on a Phase 2B protocol for its brilacidin in treating acute bacterial skin and s...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on a draft guidance on safety labeling changes to the Of...[ Price : $8.95]
Federal Register Notice; FDA plans a public hearing 12/18 to gain input on establishing a list of qualifying pathogens that have t...[ Price : $8.95]
FDA cites Janssen Biotechs Malvern, PA facility for failing to adequately investigate unexplained discrepancies related to Remicad...