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November 05, 2009
Also, FDA and WebMD increase collaboration and PPD is awarded contract to evaluate the agency's postmarket spontaneous-adverse-event surveillance system.
November 02, 2009
New tests solve one issue, but cheaper plastic and new stoppers cause problems.
October 22, 2009
The US Food and Drug Administration issued a guidance for industry and review staff titled, Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.
October 08, 2009
The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009.
October 02, 2009
Like life, the workplace also can have many surprises.
The FDA issued a proposed rule to clarify the cGMP requirements applicable to combination products in the Federal Register.
September 03, 2009
The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.
Also, FDA issues several recent enforcement letters to Cambrex, Johnson & Johnson, and Pedinol.
September 02, 2009
Thanks to their keen observations, these auditors reveal the true culprits of deviations.
September 01, 2009
The author describes the approach taken to develop a facility dedicated to handling potent and cytotoxic drug substances.