Jul 3, 2012
By:
Susan Haigney
FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen
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Jun 26, 2012
By:
Susan Haigney
FDA Updates List of Warning Letters
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Jun 19, 2012
By:
Susan Haigney
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.
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Jun 12, 2012
By:
Susan Haigney
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.
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Jun 5, 2012
By:
Susan Haigney
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."
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May 22, 2012
By:
Susan Haigney
PDA Releases Technical Report on TBA and TCA Odors and Taints
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May 22, 2012
By:
Susan Haigney
PDA Revises Technical Report on Sterilized Products
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May 15, 2012
By:
Susan Haigney
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%.
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May 1, 2012
By:
Susan Haigney
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.
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