Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. BLA process (CBER).

Development 161

Development Production Immune Response Licensing 161

Cloudbyz

OCTOBER 19, 2023

Conclusion A unified clinical trial management platform is no longer a luxury but a necessity for pharmaceutical companies aiming to thrive in an increasingly competitive and regulated industry.

Clinical Trials 104

Clinical Trials Clinical Trials Trials Compliance 104

FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Clinical Trials 64

Clinical Trials Clinical Trials Trials Drugs 64

Cloudbyz

AUGUST 9, 2023

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Integrated Compliance and Governance With stringent regulations governing clinical trials, compliance is of utmost importance.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

AUGUST 2, 2023

Meanwhile, BioMarin’s gene therapy Roctavian is approved by the FDA for the treatment of hemophilia A. In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program. But all three drugs have new competitors. Both are anti-CD20 agents.

Sales 98

Sales Manufacturing FDA Approval Life Science 98