Tag Archive: exclusivity

Aug 15

FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions

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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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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Jul 27

FDASIA, Part 2: Pediatric Drugs and Devices and Medical Device Regulatory Improvements

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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Mar 10

Therapeutics for Rare and Neglected Diseases – How Rare is Rare?

The U.S. National Institutes of Health (NIH) classifies a rare disease as affecting less than 200,000 individuals in the United States.  As insignificant as this classification may sound, collectively there are more than 25 million people in the United States affected by approximately 6,800 rare diseases. These rare diseases are alarmingly overlooked and under researched. …

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Jun 03

FDA Ups the Ante on Transparency

Transparency is not the same as looking straight through a building: it’s not just a physical idea, it’s also an intellectual one. – Helmut Jahn I’ve talked about its transparency initiative before (here, here, here, and here), but the FDA’s most recent move on the subject really takes the cake.  If you are in any …

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