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FDA warning letters to foreign drug and API manufacturing facilities have increased more than tenfold so far this year compared to the same period in 2016. Read More
Because no drugs exist for delayed graft function prevention, the FDA yesterday issued guidance to help foster discussion between drugmakers and the agency on developing drugs to treat the problem. Read More
In response to growing concerns over drug quality in India, the government is proposing to create an electronic platform to monitor its drug supply. Read More
FDA inspectors observed several violations at a VistaPharm facility in Largo, Fla., including contaminated water used in manufacturing and batches of drugs that were not tested for impurities. Read More
Australia’s Therapeutic Goods Administration increased first-time inspections of drug manufacturing facilities by 16 percent in the second half of 2016, compared to the same period a year earlier, according to the agency’s latest performance report. Read More
The World Health Organization has released a draft update to its guidelines for API and finished drug stability testing that says it reflects how stability testing has evolved since the release of the original in 2009. Read More
International generic drug regulators have published a report template for biowaiver assessments to better reconcile varying biowaiver requirements among regulatory authorities. Read More