FDA Law Blog

APRIL 8, 2025

As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA. About one third of these PSGs are for complex products and many reflect what OGD and DPD learned about the science of equivalence from GDUFA-funded regulatory science research. 314.150(c).

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Generic Drugs Drugs Bioequivalency Production 139

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.

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Generic Drugs Development Bioequivalency Drugs 52

Delveinsight

FEBRUARY 5, 2021

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Moreover, the generic drugs of Zyban are also approved, while for Chantix, its patent is soon going to expire in 2021 in the EU and in 2022 in Japan. Generics in the Market.

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Marketing FDA Approval Branding Production 52

The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches. About TLC.

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Clinical Trials Clinical Trials Trials Containment 40

Druggist

MARCH 25, 2021

As with other drugs, once a patent expires, other manufactures start to produce generic or new brands of the same pill (desogestrel). New generic drugs are usually cheaper than original patent medicine, therefore switch in prescribing follows in the NHS. Bioequivalent studies may involve humans or animals (EMA, 2012). .

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Branding Bioequivalency Pharmacy Generic Drugs 98

Drug Patent Watch

JANUARY 22, 2025

The Science Behind Generic Drug Bioequivalence: Separating Fact from Fiction As a healthcare professional or someone simply looking to stay informed, you've likely heard the term "bioequivalence" thrown around when it comes to generic drugs. Let's dive into the science behind it.

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Bioequivalency Generic Drugs Drugs Branding 81

Drug Patent Watch

JANUARY 7, 2025

Generic drugs play a crucial role in providing affordable medication options to patients. However, many individuals still harbor misconceptions and doubts about the efficacy and safety of generic alternatives. What Are Generic Drugs?

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Generic Drugs Drugs Branding Bioequivalency 89