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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
International generic drug regulators have published a report template for biowaiver assessments to better reconcile varying biowaiver requirements among regulatory authorities. 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
A response to a Form 483 is not a routine or informal communication and should be given the same attention and care you would give to defending your company from a federal indictment — because that’s what a 483 actually is. Read More