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Responses to internal audit reports are critical for GMP compliance because they fall under CAPA — so how a company responds to the findings of an internal audit is a key component of an effective audit. Read More
GMP woes for foreign and domestic facilities continued as the FDA issued three warning letters to Indian and Chinese factories as well as a U.S. facility over data integrity and quality control problems. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including ensuring GMP compliance and quality throughout supply chains. Read More
Sponsors should include clear assessments of necessary future quality improvement actions in their periodic safety update reports, not simply provide a list of adverse events or GMP problems, according to new guidance from the European Medicines Agency. Read More
Congress reached a deal late Sunday night on a comprehensive, 1,600-page bill to fund the federal government through September 30 — and give the FDA an extra $39 million. Read More
The FDA issued a Form 483 to drug manufacturer Amerigen for insufficient record-keeping and quality controls following a November 2016 inspection of the company’s Suzhou, China, facility. Read More
Pfizer called for the invalidation of three Rituxan patents covering treatments for non-Hodgkin lymphomas last week, filing separate complaints with the PTO’s patent review board. Read More
The U.S. Trade Representative flagged China and India on its latest priority watch list of countries with lax intellectual property protections for drugs. Read More
Congress reached a deal late Sunday night on a comprehensive, 1,600-page bill to fund the federal government through September 30 — and give the FDA an extra $39 million. Read More