Articles by Susan Haigney - BioPharm International

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Articles by Susan Haigney

EMA Makes Orphan Drug Recommendations

Jun 19, 2012

The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

NIH Initiative Gains Five New Companies

Jun 12, 2012

The National Institutes of Health have gained the participation of Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, and Sanofi in their effort to advance new therapeutic research.

USP Issues Change to Viscosity Reference in Monographs

Jun 5, 2012

The United States Pharmacopeia has stated that references to General Chapter <911> "Viscosity" will be changed to General Chapter <911> "Viscosity—Capillary Viscometer Methods," <912> "Rotational Rheometer Methods," or <913> "Rolling Ball Viscometer Method."

PDA Releases Technical Report on TBA and TCA Odors and Taints

May 22, 2012

PDA Releases Technical Report on TBA and TCA Odors and Taints

PDA Revises Technical Report on Sterilized Products

May 22, 2012

PDA Revises Technical Report on Sterilized Products

CDER Ombudsman Releases Annual Report

May 15, 2012

The Center for Drug Evaluation and Research Ombudsman's office released its annual report detailing the common questions and complaints received by the office in 2011. A total of 461 inquiries was received, an increase of 11% from 2010. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%.

FDA Issues Warning Letters to Ten Companies for Lack of Safety Evidence

May 1, 2012

FDA has issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine, also known as DMAA. FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.

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.

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