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Between 2015 and 2016, the number of GMP inspections conducted by European Economic Area authorities of non-EU sites dropped by nearly 25 percent, but the authorities reported more findings of non-compliance over the same time period. Read More
The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, according to a high-ranking agency official. Read More
The European Medicines Agency launched the new version of its EudraVigilance adverse event database Nov. 22, providing more tools for analysis. Read More
The FDA released a draft guidance explaining the circumstances when packages and cases are exempted from certain requirements of the 2013 Drug Supply Chain Security Act. Read More
Danish drug regulators moved to shut down a drug importer and repackager due to its inadequate quality control systems, the Danish Medicines Agency said. Read More
The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More
The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More
The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More
Ensuring data integrity is a crucial task for drug manufacturers wishing to stay out of trouble with the FDA, a top enforcement official at the agency told an industry conference. Read More
The FDA issued a warning letter to a Texas drug compounding facility after it failed to resolve problems identified during an inspection, including serious deficiencies in sterile drug processing. Read More
The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More