Articles by Susan Haigney - BioPharm International

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Articles by Susan Haigney

USP Hosts Symposium on Science and Standards

Sep 5, 2012

USP Hosts Symposium on Science and Standards

EMA Phases out Follow-Up Measures

Aug 9, 2012

The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.

Congress Passes Generic Drug Act

Jul 10, 2012

Congress Passes Generic Drug Act

FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

Jul 3, 2012

FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

FDA Updates List of Warning Letters

Jun 26, 2012

FDA Updates List of Warning Letters

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 Revises Technical Report on Sterilized Products

May 22, 2012

PDA Revises Technical Report on Sterilized Products

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