Health Canada has finalized guidance on software as a medical device (SaMD) that clarifies how it fits into the agency’s regulatory framework and how devicemakers can comply. Source: The GMP…
A federal judge has ruled that the FDA can no longer regulate barium sulfate as a drug. Source: Drug GMP Report
Switzerland’s drug agency Swissmedic rapped an Indian drugmaker for significant CGMP violations at a facility near Mumbai. Source: Drug GMP Report
The FDA has issued Form 483 inspection reports to seven drug companies for a variety of GMP and other lapses, including problems with data integrity, complaint handling and visual examinations…
Healthcare regulators have set their sights on type 2 diabetes drug metformin to see if it contains unsafe amounts of N-nitrosodimethylamine (NDMA). Source: Drug GMP Report
Four U.S. drugmakers drew FDA warning letters for violations ranging from the use of contaminated water to the promotion of unapproved drug products. Source: Drug GMP Report
Ranitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Source: Drug GMP Report
Drug imports to the U.S from Canada “will have little or no impact on U.S. drug prices,” and will cause problems for Canadians, according to Canada’s acting Ambassador to the…
The FDA cited a Huntington Beach, Calif., drug manufacturer for four violations at its facility, including a lack of data backups. Source: Drug Industry Daily
The FDA’s warning letters for 2019 once again targeted many familiar GMP failures, such as quality units that either lacked or failed to follow written procedures. Source: Drug Industry Daily