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June 08, 2015
FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.
June 05, 2015
Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.
Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.
June 04, 2015
FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.
June 02, 2015
Clearly defined zones of cleanliness must be designed and maintained to prevent product contamination.
May 29, 2015
The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.
May 28, 2015
New guidance complements ICH guidelines on impurities.
May 11, 2015
FDA issues a Form 483 following inspection of Impax Laboratories' Hayward, CA facility.
May 04, 2015
FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.
May 02, 2015
Pharma can boast of big-picture successes, but needs to work on operational issues.