Articles by Susan Haigney - BioPharm International

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Articles by Susan Haigney

FDA Reports Improvement in Postmarket Drug Oversight

Apr 24, 2012

FDA Reports Improvement in Drug Oversight.

FDA Takes Proactive Steps to Prevent Cancer Drug Shortages

Mar 6, 2012

On Feb. 21, 2012, FDA announced steps the agency plans to take to increase the declining supply of certain cancer drugs. These steps came in response to President Obama?s Oct. 31, 2011 Executive Order.

White House’s 2013 Budget Includes FDA Increases

Feb 21, 2012

President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion

FDA Recommends Three Drug User Fee Programs

Jan 24, 2012

On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and programs for human generic drugs and biosimilar biological products.

FDA Creates Shared REMS System for TIRF Medicines

Jan 10, 2012

On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, a single-shared risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products, narcotic pain medicines used by cancer patients to manage pain.

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