Tag Archive: advisory committees

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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Jul 20

FDASIA, Part 1: The “UFAs”

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 series, we will cover the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical Device Regulatory …

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May 06

Device Advisory Committee Changes

If you don’t like how things are, change it!  You’re not a tree. – Jim Rohn Planning on attending an Advisory Committee meeting for a medical device in the near future?  If you’re a regular at them, you may soon notice something different.  The FDA’s Center for Devices and Radiological Health (CDRH) recently announced some …

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Apr 28

New Disclosure Requirements for FDA Advisory Committees

Seldom, very seldom, does complete truth belong to any human disclosure. – Jane Austen On 21 April 2010, the FDA announced a newly revised Draft Guidance on Transparency and Advisory Committees.  If implemented, the draft guidance would increase transparency into the financial disclosures and conflicts of interest of Advisory Committee members. The FDA has 40 …

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Apr 07

Tips for your Special Protocol Assessment

A number of scientists with greatly different backgrounds can come up with completely different assessments. – Richard Leakey One question that we hear frequently is:  Can we apply for a Special Protocol Assessment (SPA) for our Phase 3 trial?  The answer is always “Yes, you can apply.”…but should you?  That is an entirely different question. …

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