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Samsung Bioepis suspends development for its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for interchangeable biosimilars; Alvotech receives a Form 483 after the FDA reinspected its Iceland-based manufacturing facility.
The U.S. Food and Drug Administration is screening imports of cinnamon from multiple countries for toxic lead contamination, after growing reports of children who were sickened after eating pouches of
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...
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.
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