Tag Archive: Priority Review

Feb 15 2013

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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Feb 12 2013

Everything You Need to Know About Priority Review Vouchers: Part 1 of 2

The Basics, History, and Record of the Priority Review Voucher Program The Basics If your company’s goals include funding pipeline development or increasing speed to market you should, at least, be familiar with the concept of the Priority Review Voucher (PRV). A PRV would be aptly described as an obscure or esoteric regulatory curiosity by …

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Dec 19 2012

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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Nov 19 2012

Health Canada Orphan Drug Policy – A Long Overdue Need

Canada is one of the only first world countries without an orphan drug policy. The United States, European Union, Australia, Singapore, and Japan recognized a long time ago the importance of having established policies around the development of orphan drugs. In a 1996 report from Health Canada’s Drugs Directorate that analyzed the need for an …

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Mar 20 2012

Senator Hagan’s TREAT for Small Biotech

Image via www.dog-paw-print.com Beginning with the Pure Food and Drugs Act of 1906, legislation proposed by Congress has constructed and continues to modify the FDA.  By extension this legislation represents the rulebook that biotech plays by in its pursuit of advancing drugs to market.  Longtime biotech advocate, Senator Kay Hagan (D-NC) has proposed the TREAT …

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Apr 19 2010

Drug/Biologic/Device Highlights from the Health Care Reform Bill

Cautious, careful people, always casting about to preserve their reputations… can never effect a reform. – Susan B. Anthony Last month, the company behind the FDA Law Blog, Hyman, Phelps & McNamara, P.C., prepared a memo that outlines the provisions in the Patient Protection and Affordable Care Act (commonly known as the “Health Care Reform …

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