FDA's Commitment to Clarity: Navigating Distributed Manufacturing Regulations
The US Food and Drug Administration (FDA) has reaffirmed its commitment to providing guidance on the regulation of distributed manufacturing (DM) and point-of-care manufacturing of drugs and biologics. The hope is that issuing this guidance will clear up regulatory ambiguities and spur technological adoption. The International Society for Pharmaceutical Engineering (ISPE) is among two major pharmaceutical industry groups which told the FDA that additional guidance was needed to clear up ambiguities with how DM will be regulated. For a deeper understanding of the FDA's approach and the industry's perspectives, delve into the full article.
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