FDA Law Blog: Biosimilars

MARCH 29, 2024

That report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony. Complete numbers for 2023 and 2024 are not available, but it appears that FDA was only able to complete 537 BIMO inspections in 2022. The vast majority are for drugs. The stakes remain high, though.

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Agency IQ

DECEMBER 11, 2023

In addition, the District of South Carolina will hold an additional final fairness hearing on February 2, 2024, to determine whether the 3M settlement should be certified as a class for the purposes of the settlement and whether the proposed settlement is “fair, reasonable, and adequate.”

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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. OIG claims a review will be complete in 2024. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. 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.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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Agency IQ

MARCH 25, 2024

Senate hearing on hazardous substance listing for PFAS finds common ground, but disagreements on implementation tactics The Senate Committee on Environment and Public Works held a hearing on March 20, 2024, reviewing the issues and possibilities for designating PFAS as hazardous substances under the federal Superfund law.

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Testimonials Regulations Government Immune Response 40

Agency IQ

SEPTEMBER 29, 2023

AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of the law are still due to come into effect in late November. Review to take place within 21 days. to include devices.

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