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.

Bioequivalency 59

Bioequivalency Generic Drugs Packaging Packaging 59

Camargo

NOVEMBER 11, 2020

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. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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Development Bioequivalency Generic Drugs Production 242

Drug Discovery World

AUGUST 22, 2023

This will continue to be the case going forward, but the nature of the off-patent landscape will evolve in line with ongoing changes in the segment’s ‘pipeline’: the originator products of today, which will become the generic and biosimilar medicines of tomorrow. What are complex generics?

Production 52

Production Bioequivalency In-Vivo In-Vitro 52

Drug Discovery World

APRIL 10, 2023

Thanks to a new focus on R&D, increasing digitalisation and government investment, India is establishing itself as a significant player in drug discovery, and the Hyderabad life sciences hub has played a significant role in this. India’s domestic pharmaceutical market is expected to reach US$120-130 billion by 2030 2.

Genome 52

Genome Genomics Drugs Life Science 52

World of DTC Marketing

JANUARY 31, 2021

Porter points out that R&D seems to have been replaced with mergers and acquisitions, but she misses the big picture by focusing solely on drug costs. So where to start… Congresswoman Porter may want to look at the percentage of generic drugs available virus branded (89%). In pharma R&D returns have declined to 1.8

In-Vivo 187

In-Vivo Generic Drugs Gene Therapy Drugs 187