FDA Law Blog: Biosimilars
APRIL 16, 2024
Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).
FDA Law Blog: Biosimilars
APRIL 3, 2023
Kirschenbaum — On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). Examples in the regulation include extended-release formulations, new strengths, dosage forms, routes of administration, ingredients, and combinations.
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FDA Law Blog: Biosimilars
JUNE 13, 2024
While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R. b)(1) that drug product patents may be listed if they claim the “drug product. that is described in the pending or approved NDA ” (emphasis added). .
European Pharmaceutical Review
DECEMBER 1, 2023
Dr Kane leads a team of subject matter experts at Thermo Fisher, covering drug products in both sterile injectable dosage and oral solid dosage forms. Small molecules continue to be of interest going into oral solid dosage forms” AK: That’s a very interesting question that can be addressed in a few different ways.
FDA Law Blog: Biosimilars
FEBRUARY 26, 2024
Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R. FDA replied that its definition of strength including concentration was clear even in 2009. mg) and the concentration (e.g., mg/mL) for liquid parenteral drug products.
FADIC
JULY 14, 2024
OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. Its OTC drug section covers a broad range of OTC medications, offering detailed descriptions, recommended dosages, and potential drug interactions.
pharmaphorum
OCTOBER 11, 2022
In addition, RCTs don’t have to rely on two different data sources, which may have different operational definitions, assessment methods, and measurement timing. eligible dosages, how the drug is administered, and frequencies of drug intake). However, in certain cases, RCTs are unfeasible and this is when SATs can be utilised.
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