Camargo

NOVEMBER 11, 2020

Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations).

Development 242

Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

Bioequivalency 130

Bioequivalency Production Branding Contamination 130

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Expanded access to experimental biologics. BLA process (CBER).

Development 161

Development Production Immune Response Licensing 161

The Pharma Data

AUGUST 5, 2020

Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. J Neurol Sci.

Trials 52

Trials Medicine Production Containment 52