The Premier Consulting Blog
OCTOBER 1, 2023
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.
Agency IQ
MARCH 15, 2024
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%.
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The Pharma Data
JUNE 26, 2021
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.
Agency IQ
SEPTEMBER 6, 2023
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.”
The Pharma Data
APRIL 7, 2021
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.
Agency IQ
FEBRUARY 23, 2024
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.
Agency IQ
SEPTEMBER 15, 2023
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.
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