Agency IQ

JUNE 29, 2023

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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Agency IQ

SEPTEMBER 29, 2023

What we expect to be talking about in October: Government shutdown: The odds of a government shutdown happening in October are, we think, rather high absent a last-minute breakthrough in Congressional negotiations. Of note: A government shutdown would likely delay or cancel some of the events listed below.

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Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. federal government has appropriated funding through November 17. That means at 12:01 on November 18, the government will shut down unless Congress is able to pass either a full budget (unlikely) or a continuing resolution (more likely).

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Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published.

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Agency IQ

JULY 28, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUN 27, 2023 11:49 AM CDT Big-picture things to watch in Q3 A rush of things for FDA to do as we approach the end of the fiscal year: The government operates on a Fiscal Year that begins on October 1 each year and ends on September 30. government by October 1.

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