Tag Archive: user fees

Feb 15

Everything You Need to Know About Priority Review Vouchers: Part 2 of 2

The Rare Pediatric Disease PRV, the Difference in the PRVs, and the Future of the Program The Rare Pediatric Disease Priority Review Voucher (If you haven’t read Part 1 yet, start there first!) A new Priority Review Voucher (PRV) has been introduced that could be a game changer with respect to the program.  Nancy Goodman …

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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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Jul 16

New Provisions in the FDA Safety and Innovation Act (aka PDUFA V)

Seal of the U.S. Congress

On 09 July 2012, President Obama signed FDASIA (otherwise known as PDUFA V) into law. The reauthorization of PDUFA V has been working its way through both houses of Congress since May and has received uncharacteristically broad bipartisan and bicameral support. In 2007, PDUFA IV was hotly debated between the two chambers and was barely passed in time to replace the expiring PDUFA III, but this time, lawmakers were able to meet their goal of sending the President a reconciled bill well before the 30 September expiration date of PDUFA IV.

The new law will go into effect on 01 Oct 2012 and will sunset on 30 Sept 2017.

The FDASIA includes the following provisions

May 07

New FDA Guidances from April 2012

Here’s a list of the notable guidances released by FDA in April 2012.