Bioequivalency Containment Regulation 
Camargo
NOVEMBER 11, 2020
Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations).
Drug Patent Watch
JANUARY 14, 2025
The Thyroid Association’s Concerns The American Thyroid Association (ATA) had raised concerns about the FDA’s methods for determining bioequivalence between levothyroxine products[2]. They recommended avoiding switching between levothyroxine products, leading to a preference for brand-name prescriptions.
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Pharmaceutical Technology
OCTOBER 28, 2022
To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.
Camargo
DECEMBER 13, 2021
The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. An application submitted under 351(a), also known as a “stand-alone” application, must contain all safety and effectiveness information for a biological product and cannot depend on any other biological product.
FDA Law Blog
FEBRUARY 26, 2024
314.3 , codified in 2016, which defines strength as the “ total quantity of drug substance in mass or units of activity in a dosage unit or container closure” and/or “the concentration of the drug substance.” FDA explained that its bioequivalence regulations at 21 C.F.R. FDA borrowed this definition from 21 C.F.R.
Delveinsight
FEBRUARY 5, 2021
The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Some of these approved products contain nicotine as an active ingredient, while others do not. Quitting smoking is an arduous, exhausting process. However, it is possible.
The Pharma Data
AUGUST 5, 2020
Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. J Neurol Sci.
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