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PDUFA VII will be in effect from fiscal year 2023 through fiscal year 2027. It is the sixth reauthorization of PDUFA that provides the FDA with necessary resources and includes provisions to increase the efficiency of the drug development process. Check out our previous blog post to learn more about changes that came in PDUFA VII.
Sponsors should prepare by reviewing implementation packages from the ICH and applicable regions. Implementation Package v1.5 Implementation Package v1.5 Module 1 Implementation Package FDA eCTD v4.0 The agency will begin accepting eCTD v4.0 How can you prepare? How can you prepare? FDA eCTD v4.0
To date, the company has already notably: reduced GHG emission from its activities by 27% since 2015; designed a new entirely recyclable cardboard packaging for vaccines, which replaces aluminum and PVC blisters; reused, recycled, or recovered 73% of its waste; and reduced by 22% its water withdrawal from 2015 to 2020.
Background: SB 54 and its requirements On June 30, 2022, Governor Gavin Newsom signed into effect SB 54, the Plastic Pollution Prevention and Packaging Producer Responsibility Act. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.
Zero plastic packaging for vaccines and ecodesign of products. To reduce its greenhouse gas emissions by 55% by 2030 and contribute to better resource conservation, Sanofi plans to remove all pre-formed plastic packaging (blister packs) for its vaccines by 2027.
In FY2025, that will increase to a goal of 70%, and in FY2026-2027, it will increase to 80%. The meeting package should contain sufficient detail to meet the intended meeting objectives,” and should also “clearly indicate” the purpose of the meeting and allow FDA to “assess the potential utility of the meeting.”
of the California Safe Drinking Water and Toxic Enforcement Act of 1986, the European Union’s (EU) Regulation on the Registration, Evaluation, Authorization of Chemicals ( REACH, 1907/2006 ), and the EU’s Classification, Labeling, and Packaging Regulation ( CLP 1272/2008 ), among others.
In the same month, the California Department of Toxic Substances Control (DTSC) presented its chemical profile for carpets and rugs containing PFAS as well as a webinar for its findings on PFAS in food packaging. DTSC would be required to adopt regulations by January 1, 2027, to administer the bill.
GDUFA III), which reauthorized the program through 2027. Two items should be submitted concurrently to the FDA by sponsors seeking a PSUB meeting: 1) the actual meeting request and 2) the meeting package. The generic drug user fee program is currently on its third iteration (i.e., What to expect on the day of the meeting?
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.
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.]
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.”
However, “we’ve decided to postpone that for a year until fiscal year ‘25, and this will allow us to take the learnings that are accruing from the Innovation Center and elsewhere so that we can develop all the technical requirements to enhance the data and service package[s] available to FDA.”
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.
For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. Specifically, EPA proposed stronger CO2 standards for MY 2027 HD vehicles that go beyond the current standards that apply under the HD Phase 2 Greenhouse Gas program.
This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration. The standards would begin with model year 2027 heavy-duty vehicles, with stringency levels through model year 2030 and beyond.
This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration. The standards would begin with model year 2027 heavy-duty vehicles, with stringency levels through model year 2030 and beyond.
But despite the law’s age, it is not yet fully operational. October 1, 2023 MDUFA Total Product Life Cycle (TPLC) Advisory Program (TAP) As part of TPLC pilot program effort: In FY 2024, continue to support products enrolled in the previous fiscal year and expand to enroll up to 45 additional products in at least two OHTs (i.e.,
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