Agency IQ

NOVEMBER 20, 2023

Sentinel Update: PDUFA projects, ARIA sufficiency and building out a method for causal inference FDA’s Sentinel Initiative, the post-market, real-world data surveillance system, is nearing the end of its current five-year strategic plan. The Sentinel Initiative was kicked off in 2008 under the FDA Amendments Act (FDAAA).

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Agency IQ

AUGUST 2, 2024

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed. legislation The list below includes legislation proposed by the European Commission that is yet-to-be-published.

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Agency IQ

MAY 17, 2024

Ultimately, industry is wagering that increased regulatory efficiency—which it pays for—will benefit its products through faster review times, more certainty and more time on the market for its products. GDUFA III), which reauthorized the program through 2027. The generic drug user fee program is currently on its third iteration (i.e.,

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Agency IQ

OCTOBER 6, 2023

France In January, the French ecology ministry published a PFAS action plan enumerating six objectives for regulating forever chemicals more comprehensively by 2027. [For an in-depth analysis of this restriction proposal, read AgencyIQ’s February 10, 2023 article here.]

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Agency IQ

JUNE 28, 2024

The bill originally defined “ product ” with a similar wide latitude, as “an item manufactured, assembled, packaged, or otherwise prepared for sale in California, including, but not limited to, its components, sold or distributed for personal, residential, commercial, or industrial use, including for use in making other products.”

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Agency IQ

MARCH 29, 2024

March 2024 Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 (Final Rule Stage) 2060-AV50 On April 12, 2023, EPA announced a proposal for more stringent standards to reduce greenhouse gas emissions from HD vehicles beginning in model year (MY) 2027. 7521(a), starting with model year 2027.

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Agency IQ

DECEMBER 1, 2023

2060-AV59 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management. Regan, Case No: 1:16-cv-00364-CRC (D.D.C.

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