Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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Development Bioequivalency Generic Drugs Production 242

FDA Law Blog

FEBRUARY 26, 2024

As FDA explains, Boehringer’s request would allow its “Cyltezo (adalimumab-adbm) injection, which contains the same total content of drug substance and same concentration as Original Concentration Humira (e.g., mg/mL) for liquid parenteral drug products. FDA explained that its bioequivalence regulations at 21 C.F.R.

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Production Bioequivalency Drugs Containment 59

FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. The PTE application states “[u]nder the terms of the AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT between Pfizer Inc. exclusively licensed U.S. 27, 1995); aff’d , 109 F.3d

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Marketing Production FDA Approval Generic Drugs 59

XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

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Production Insulin Branding Generic Drugs 78

Pharmacy Checkers

JANUARY 10, 2020

We know there are many doctors, nurses and other prescribing medical professionals who recommend PharmacyChecker or have learned of trusted licensed foreign pharmacies though their own research. Other medical professionals, however, are subject to the same scare tactics as consumers, ones perpetrated by drug company-funded organizations.

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FDA Approval Branding Pharmacy Manufacturing 62

Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. She also does not believe that the problems with Europe’s medicines can be solved with regulation. appeared first on Drug Discovery World (DDW).

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Clinical Trials Clinical Trials Production Medicine 52

Pharmaceutical Technology

AUGUST 12, 2022

This trade has been able to continue for the most part, as the UK’s regulator (the MHRA) remains aligned in many areas with the EU’s regulator (the EMA). Even following the Brexit vote, the EU remains the UK’s largest trading partner, and a high proportion of UK drugs originate from European countries.

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