FDA Law Blog
MARCH 5, 2023
Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. FDA may deny a PSG if the applicant’s bioequivalence testing started after the PSG publication.
Pharmacy Checkers
FEBRUARY 14, 2020
Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. Several years later, the FDA ordered bioequivalence tests and finally, through those results, which found, like ConsumerLab.com did, that the People’s Pharmacy was right, and forced the drug off the market. Below are U.S.
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FDA Law Blog
JULY 24, 2022
TE Codes, FDA explains, are assigned for multisource prescription products based on pharmaceutical equivalence, bioequivalence, and product safety and efficacy profile for the conditions of use specified in the labeling. FDA goes through each of the relevant terms and the therapeutic equivalence requirements.
Pharmaceutical Technology
JANUARY 6, 2023
The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. In vitro release testing to demonstrate bioequivalence.
Pharmaceutical Technology
FEBRUARY 23, 2023
The BCS is a regulatory tool that is used to justify clinical biowaivers for certain types of compounds (BCS Class I and III) based on dissolution data, allowing sponsors to justify not performing clinical bioequivalence studies when changing a formulation. A recent example of this was for a compound at the candidate selection stage.
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