Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists.

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FDA Science Regulations Production 40

Agency IQ

JUNE 16, 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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Regulations FDA Science Production 40

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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FDA Science Regulations Production 40

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). to include devices.

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FDA Science Regulations Production 40

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. 2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. Polansky v. 3d 239 (Cal.

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Testimonials FDA Drugs Vaccine 105

Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. In at least the short term, a popular pain reliever would have to be removed from pharmacies. Wyeth Laboratories, Inc. ,

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FDA FDA Approval Testimonials Vaccine 59