Tag Archive: accelerated approval

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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Jun 06 2012

New FDA Guidances Released in May 2012

Here’s a list of the  guidances released by FDA in April 2012, compiled by Cato Research Scientist Elinore Mercer, Ph.D. Pediatric Information for X-ray Imaging Device Premarket Notifications (Draft) S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval (Draft) …

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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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Aug 11 2010

Accelerated Approval

Image via Wikipedia One must strike the right balance between speed and quality. – Clare Short Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics:  What is accelerated approval and how does it work? The process is defined in 21 …

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May 17 2010

DDMAC Sends Warning Letter Over Unbranded Websites

If you judge, investigate. – Seneca I know you just read the title, but let me say it again with some emphasis:  DDMAC Sends Warning Letter Over Unbranded Websites.  That’s right, a warning letter over websites that contained no “direct” references to a product…although, as we’ll see, the indirect references were too direct for the …

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