FDA Releases Draft Guidance On Use Of Real-World Evidence For Drug & Biological Products
The FDA has issued new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data (RWD) and real-world evidence (RWE) into clinical research, product approvals, and post-approval monitoring of drugs. You can submit public comments until March 3, 2022.
Building The Right Team for FDA Approval of Your Innovative Medtech
Navigating the complexities of the FDA’s approval and regulatory process for medical devices can be daunting for all companies and particularly stressful for new technologies with disruptive innovation. However, the FDA is best regarded as a partner and not an obstruction. If your device development team does their homework, you'll have a successful product.
Regulatory Intelligence: It’s More Than Just Compliance
Every pharmaceutical company is under pressure to monitor the changes that are taking place in the regulated landscape and respond to them accordingly. Regulatory intelligence activities include collecting, evaluating, and analyzing various pieces of information to position your company for success.
Can the FDA & CDC Recover from Recent Politics?
Five leading biopharma executives discuss the perils of political influence over the FDA and CDC and why every member of the industry should care.
Marks Took On FDA Vaccine Leadership Position – What Happens Now?
Center for Biologics Evaluation and Research Director Dr. Peter Marks decided to temporarily take on the leadership of the Office of Vaccine Research and Review after both its director, Marion Gruber, and deputy director, Philip Krause, unexpectedly announced in late August their decisions to exit the FDA.
Why Korea Is Now More Attractive To U.S. Biopharma
A quirk in Korea’s patent laws made it relatively difficult to secure patent protection for many drugs. That is, until this year.
U.S. Biopharma Manufacturing: Not An Overhead Cost But A Value Center!
Jeff Baker, previously of the FDA, comments on what he sees as the shortcomings of the industry’s approach to biopharma manufacturing.
New Therapies Require A New Approach To Regulatory Interactions — A Discussion With bluebird bio’s Scott Cleve
bluebird bio's Scott Cleve recently sat down with The Business of Biotech to talk about shifting regulatory standards and how pharmas can adapt how they engage with regulators.
Apply For A Breakthrough Therapy Designation (And Win It!)
GlaxoSmithKline's Dr. Ira Gupta and Gilead Sciences' Dr. Shanthi Ganeshan break down breakthrough designations, winning them, and bouncing back from rejection.
How To Prepare For A Remote Regulatory Inspection
Remote regulatory inspections were a significant change that occurred during the COVID-19 crisis. Considering these will continue even after the pandemic, we’ve compiled some tips on how to prepare and what to expect from a remote inspection.