Branding Containment Generic Drugs Regulation 
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.
The Pharma Data
MARCH 15, 2022
Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.
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FDA Law Blog
MARCH 26, 2024
Late last week, the FTC submitted an Amicus Brief in recent Hatch-Waxman patent litigation in the District Court of New Jersey between Reference Listed Drug holder Teva Branded Pharmaceutical Products R&D Inc. Because a “drug product” is defined by regulation as a “Finished dosage form.
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. Generics in the Market. Generic medications are the same as the original branded ones, but cheaper.
The Pharma Data
OCTOBER 14, 2020
The company’s Specialty Brands reportable segment’s areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. © 2020 10/20.
Pharmacy Checkers
NOVEMBER 21, 2019
Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . It’s primarily the FDA’s role over drug safety and quality that captures my interest and admiration.”.
The Pharma Data
MAY 4, 2021
On December 21, 2020, which falls in Pfizer’s international first-quarter 2021, Pfizer and Viatris completed the termination of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (Mylan-Japan collaboration) and Pfizer transferred related operations that were part of the Mylan-Japan collaboration to Viatris.
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