ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

FDA Guidance Documents are Vital in De-Risking REMS

The FDA’s risk evaluation and mitigation strategy (REMS) requirements are among the most demanding of a pharmaceutical or biotech manufacturer’s postmarket requirements, and it is important to plan adequately for these programs, given the cost of a failed first attempt.

Wondering which QMS is right for you?
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