Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., OIG claims a review will be complete in 2024. not discontinued) and are available for sale.

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FDA Science Regulations Production 40

Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. This week, CDER published its guidance agenda for 2024.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

JUNE 9, 2023

The problems: Although the current regulation stimulated orphan drug research, it didn’t do enough The regulation fostered development of medicines for rare diseases since implementation, but not enough. However, 95% of the over 6,000 recognized orphan diseases still have no treatment options. member states.

Marketing 40

Marketing Biosimilars Regulations Drugs 40

Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., OIG claims a review will be complete in 2024. not discontinued) and are available for sale.

FDA 40

FDA Science Regulations Production 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.

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FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S.

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FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

The date on which the FDA would no longer have Congressionally-appropriated funding with which to continue its operations POLITICO / 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 (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

JULY 28, 2023

September 2023 Legislative deadlines in Q3 Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.” That would leave 19% of staff affected by furloughs.

FDA 40

FDA Science Biosimilars Regulations 40

Drug Discovery World

JULY 26, 2024

The 2024 US election: Pharma in the crosshairs In the US, both main parties are pledging to reform the pharma industry and, while their approaches may differ, both Donald Trump and now Kamala Harris are expected to focus on drug pricing and market competition, signalling potential upheaval for the industry, whoever wins.

Science 130

Science Government Biosimilars Marketing 130