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Article FDA Thank You Explainer: What a government shutdown would mean for the FDA (Updated)

Agency IQ

For example, statutorily, the prescription drug user fee program (PDUFA) has a statutory cap of total carryover for operating reserves of 14 weeks, while the biosimilar user fee program (BsUFA) had a goal of bringing the carryover balance down to “no greater than 21 weeks of operating reserves” by the end of the 2022 fiscal year.

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

Agency IQ

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94

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

Agency IQ

Title Type Date Received by OIRA Legal Deadline Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format Final Rule May 19 None Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses (..)

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

Agency IQ

Title Type Date Cleared by OIRA Legal Deadline None Notable FDA Comment Periods Closing in November and December FDA comment periods are typically open for 30-60 days, unless they are extended.

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

Agency IQ

12/29/2023 FDORA, Section 3202 Orphan Drug Program : FDA will convene a public meeting (or several) to solicit input from stakeholders regarding rare disease patient burdens, treatment options, side effects of treatments, etc. Within 180 days, FDA will release a report on the proceedings of the public meeting and any recommendations.

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Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. That would leave 19% of staff affected by furloughs. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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