Tag Archives: infectious disease

FDA: The Year in Review (2012)

On 10 Dec 2012, the FDA released a report titled, “FY 2012 Innovative Drug Approvals,” which discusses the FDA’s 2012 novel drug approvals and the focus on the advancement of regulatory science in to improve the drug approval process. Thirty-five … Continue reading

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New FDA Guidances from September 2012

There were only a few guidances released by FDA in September 2012: Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products Final Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion Complicated … Continue reading

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FDASIA, Part 3: Generating Antibiotic Incentives Now (GAIN) and Drug Approval and Patient Access Changes

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: … Continue reading

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