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The FDA is pressing a GlaxoSmithKline subsidiary to make a hard choice about operations at a U.K. plant: either decontaminate the whole facility to address repeated problems with penicillin contamination or else restrict production to penicillin. Read More
British authorities have cited a U.S. drugmaker and an Indian drugmaker in recent weeks over multiple critical GMP violations at their facilities. Read More
The FDA has continued to hammer manufacturers with Form 483 citations, as evidenced by three in recent months tackling everything from sterility issues and data integrity to lax recordkeeping. Read More
The FDA has cited five U.S.-based drug compounders in as many weeks, with most of the complaints focusing on sterility issues, although questions of adulteration and issuing unapproved drugs also surfaced. Read More
To drive the manufacturing of advanced therapies, industry is asking the European Medicines Agency to provide further guidance, to harmonize EU regulations and to exercise flexibility. Read More
The FDA has stepped up its enforcement efforts in Taiwan and mainland China in the past month, issuing warnings to two Taiwanese drugmakers and two Chinese companies. Read More
The European Medicines Agency is recommending that drugmakers update their risk management plans when switching to a new manufacturing process for products with centralized marketing authorization. Read More
The time and effort to collect quality metrics dictated in an FDA draft guidance are about three times higher than the agency’s original estimates. Read More
Two Indian drugmakers risk losing their EU marketing certificates this month after regulators in France and Croatia turned up a multitude of GMP violations. Read More