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FDA Guidance On Continuous Manufacturing Of Drug Substances And Drug Products - Food and Drugs Law

In March 2023, the FDA issued a final guidance, titled "Q13 Continuous Manufacturing of Drug Substances and Drug Products" that describes scientific and regulatory considerations for the development. ....

Drug Substances , Fda Guidance , Energy And Natural Resources , Life Sciences , Food And Drugs Law ,

Podcast about the FDA's CDS Software Guidance

The FDA issued a final guidance document clarifying how the agency intends to regulate clinical decision support software. Epstein Becker Green attorneys analyze the FDA’s latest CDS guidance and discuss the challenges as the industry makes sense of and comply with guidance. ....

Epstein Becker , Food And Drug Administration , Sds Software , Clinical Decision Support , Healthcare Guidance , Fda Guidance , Healthcare Technology ,

FDA Infant Formula Discretion Policy

FDA announced enforcement discretion policy which would allow certain non-compliant infant formula to be marketed in the US,which will remain in effect until November 14, 2022.FDA taking additional steps to facilitate use of Infant Formula under enforcement discretion policy ....

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