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Early FDA Feedback with Type D Meetings

The Premier Consulting Blog

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.

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Transitioning to eCTD v4.0

The Premier Consulting Blog

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

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Analysis Chemical Thank You California publishes draft regulations for landmark plastic pollution reduction act

Agency IQ

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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Article FDA Thank You How to handle a warning letter: FDA’s new meeting type benefits generic drug companies

Agency IQ

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.”

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Article Periodic Thank You California set to ban an additional 26 chemicals from cosmetics

Agency IQ

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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Analysis Chemical Thank You Spurred by NRDC report, California senator proposes state ban on PFAS

Agency IQ

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.

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Analysis Life Sciences Thank You How have pre-submission meetings for generic drug applicants changed under GDUFA III?

Agency IQ

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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