Camargo

DECEMBER 22, 2021

In addition, the size and complexity of a development program can vary significantly depending on product characteristics, market dynamics, and regulatory pathway. Clinical pharmacology may also involve comparative bioavailability analyses, which are generally required for drug formulation bridging studies, to demonstrate bioequivalence.

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

FDA Law Blog

NOVEMBER 6, 2023

In response, we learned that only about seven – and certainly less than 10 – RIEs for manufacturing compliance have been performed at drug facilities in the last 30 months. The current and earlier guidances note that declining an RIE may delay regulatory decisions, such as approvals of applications for marketing authorization.

Manufacturing 105

Manufacturing Compliance Drugs Clinical Trials 105

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. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances.

Development 242

Development Bioequivalency Generic Drugs Production 242