Bioequivalency Generic Drugs Medicine 
Drug Patent Watch
JANUARY 14, 2025
The Generic Drug Revolution: Setting the Stage Before we dive into the nitty-gritty, let’s take a moment to appreciate the impact of generic drugs. Why Generic Drugs Matter Generic drugs are the Robin Hoods of the pharmaceutical world, stealing from the rich (brand-name drugs) and giving to the poor (our wallets).
Drug Patent Watch
DECEMBER 10, 2024
Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.
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Camargo
NOVEMBER 11, 2020
In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. for patients with NTRK fusion cancer across all solid tumors.
Drug Patent Watch
DECEMBER 10, 2024
Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy.
Pharmaceutical Technology
JULY 25, 2022
Margins in the generics market are overall being driven down, Harvard Medical School Health Economics professor Richard Frank, PhD, tells Pharmaceutical Technology. As more competitors enter the market, the price of a treatment goes down, explains Stanford University professor of medicine Dr. Kevin Schulman.
Pharmaceutical Technology
OCTOBER 28, 2022
It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. In the case of generics, the only concerns you might see is where the brand name and generic drug contain different excipients,” explained Dr Amiji. “A
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. Indeed, PSGs help facilitate generic competition, and to date, OGD has published more than 2,000 PSGs.
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