Agency IQ

SEPTEMBER 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. Both sections 503A and 503B provide that a compounded drug is not eligible for those exemptions if it is identified by FDA as presenting demonstrable difficulties for compounding.

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Agency IQ

MARCH 1, 2024

Government shutdown: At present, the FDA has appropriated funding lasting until midnight on Friday, March 1. Given that the rule is currently under White House review, we’re expecting this to soon be released. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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Agency IQ

FEBRUARY 2, 2024

Government shutdown: At present, the FDA has appropriated funding March 1. QMSR final rule : For years, the FDA has been talking about harmonizing its Quality System Regulation with ISO 13485:2016, which it would incorporate by reference. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

raw scores, standardized norm-referenced scores), some of which might present floor or ceiling effects; and ensuring that selected COAs have demonstrated reliability across demographic groups. Considering that, the safety data generated during clinical trials may not capture all possible delayed adverse events.”

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Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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