Simplifying Global Compliance
When a company applies for FDA approval to market a new regulated drug product, the agency conducts a preapproval inspection (PAI) to ensure the firm has pursued approval in an appropriate manner and is capable of producing its drug in compliance with current good manufacturing practices (cGMP). The run-up to inspection begins once the FDA assigns a company’s request for evaluation to the appropriate district office. Once that district office receives a request, it determines, using its risk assessment criteria, whether the application warrants an in-person inspection and, if so, how extensive it should be. Read More
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