Camargo
NOVEMBER 11, 2020
The ANDA application must contain a basis of submission specifying the RLD, and the applicant must show that the proposed generic drug is the same as the RLD with respect to active ingredient(s), dosage form, route of administration, strength, labeling, and conditions of use, among other characteristics.
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.
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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.
FDA Law Blog
SEPTEMBER 11, 2024
But risk also lurks from vendor-sourced raw materials containing nitrosamine impurities, or from simple deviations in temperature or pH. Note here that those initial risk assessments need not be reported, but FDA recommends that firms do report resulting changes to drug specifications like stability or bioequivalence.
Camargo
DECEMBER 13, 2021
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. Section 351(a) is the traditional pathway for approving biologics under the PHS Act.
The Pharma Data
DECEMBER 28, 2020
Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. However, not all forward-looking statements contain these words. ” According to IQVIA, the U.S.
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.
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