Tag Archive: infectious disease

Dec 19

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 novel drugs were approved by the FDA in 2012, matching the number of approvals in …

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Oct 05

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 Intra-Abdominal Infections: Developing Drugs for Treatment  Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with …

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Aug 07

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: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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