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.

Development 242

Development Bioequivalency Generic Drugs Production 242

FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. After all, it never invested the time and resources necessary to obtain approval for commercial marketing or use. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. Men in Black from the PTO’s PTE branch might have gotten to us. Lehman , No. 95-650-A (E.D.

Marketing 59

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.

Production 78

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.

FDA Approval 62

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.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

Pharmaceutical Technology

AUGUST 12, 2022

Among the negative effects that have been reported are supply chain disruptions, skills shortages, issues around market authorisation, and added costs for pharma CMOs. 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).

Medicine 290

Medicine Production Generic Drugs Regulation 290

Druggist

MARCH 8, 2021

In the UK, modafinil has narrow licensed use. The second licensed use of modafinil covers individuals who experience excessive sleepiness , defined as difficulty keeping wakefulness and an increased likelihood of falling asleep in inappropriate situations (eMC, 2020). Is modafinil a smart drug? Modafinil alternatives drugs.

Drugs 90

Drugs Licensing Licensing Doctors 90