The Premier Consulting Blog

OCTOBER 1, 2023

The FDA introduced the Type D Meeting on October 1, 2022, as part of the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter. Prescription Drug User Fee Act (PDUFA) VII The Prescription Drug User Fee Act (PDUFA VII) is a law that was signed and took effect on September 30, 2022.

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Agency IQ

SEPTEMBER 6, 2023

FDA Warning Letters are often sent to manufacturers of generic drugs. Such products are often made in foreign facilities by staff less experienced with FDA regulatory requirements and at margins which may preclude significant investments in drug quality.

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Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. One of the core goals of the GDUFA program has been to increase the efficiency of the generic drug review program.

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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

NOVEMBER 20, 2023

During an annual update on the program and its various workstreams, regulators and researchers discussed ongoing projects at Sentinel, its work under the current Prescription Drug User Fee authorization (PDUFA) program and next steps in using active surveillance for regulatory purposes.

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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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Agency IQ

SEPTEMBER 15, 2023

SEP 11, 2023 10:49 PM CDT Regulatory background Cosmetic ingredients in California are governed by the Federal Food, Drug & Cosmetic Act (FD&C Act), which provides that cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration ( 21 CFR 701.3 ).

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