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.
Drug Patent Watch
FEBRUARY 17, 2025
The ANDA must also demonstrate that the generic drug is bioequivalent to the brand-name drug. Step 4: Labeling and Packaging Once the generic drug is approved, the manufacturer must ensure that its labeling and packaging comply with FDA regulations. Generic drugs must demonstrate bioequivalence to their brand-name counterparts.
Drug Patent Watch
JANUARY 7, 2025
They’re designed to be bioequivalent, meaning they have the same dosage, strength, route of administration, quality, and intended use as the original brand-name drug. For example, instead of saying “bioequivalent,” you might say “works the same way in the body.” What Are Generic Drugs?
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