Simplifying Global Compliance
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GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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India to Regulate Gowns, Drapes as Devices
The Medical Technology Association of India says will work with its member companies to streamline the transition.
Solicitor General OK’d to Argue for Merck in Fosamax Case
The case addresses when an FDA decision to reject proposed labeling changes of a brand drug pre-empts failure-to-warn laws.
Pharmaceuticals
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