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.
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.
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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
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.
Agency IQ
MAY 17, 2024
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?
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