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The FDA released final guidance on its Q7 guidelines on good manufacturing practices for APIs, using a question and answer format to clarify the document developed through the International Conference on Harmonization. Read More
The FDA released final guidance on its Q7 guidelines on good manufacturing practices for APIs, using a question and answer format to clarify the document developed through the International Conference on Harmonization. Read More
The biggest challenge for the FDA’s 10-year-old Sentinel program for post-market safety monitoring of medical products is having to deal with a wide range of partners and data sources, according to CDER Deputy Director Robert Ball. Read More
The FDA observed various GMP deficiencies in an inspection of a Legacy Pharmaceuticals Switzerland facility, including problems with sterility, maintenance and discrepancy investigations. Read More
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the latest update from the UK’s Medicines and Healthcare products Regulatory Agency. Read More
Problems with quality topped the list of major good distribution practice deficiencies in 2016, according to the UK’s Medicines and Healthcare products Regulatory Agency. Read More
The European Medicines Agency’s quality and safety working groups intend to tackle several new guidelines this year, covering the sterilization of products and containers, risk-based prevention of cross contamination in manufacturing and requirements for products containing a device delivery component. Read More
The FDA flagged facilities in Italy, India and China for noncompliances including inadequate testing, complaint handling, and quality data, among other violations. Read More