Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. FDA’s cough cold monograph only designates two oral products as GRASE – phenylephrine and pseudoephedrine.

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Agency IQ

SEPTEMBER 29, 2023

This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat diseases or conditions and would harmonize, to the extent practicable and consistent with statutory provisions, with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies.

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Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3607 Clinical Trials Modernization : FDA must issue or revise draft guidance regarding “the use of seamless, concurrent, and other innovative clinical trial designs.” The content will include both goals for enrollment of populations and rationales for those goals.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3607 Clinical Trials Modernization : FDA must issue or revise draft guidance regarding “the use of seamless, concurrent, and other innovative clinical trial designs.” and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S.

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Agency IQ

JUNE 16, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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