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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in December and January FDA comment periods are typically open for 30-60 days, unless they are extended. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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