Approval Regs Must Change To Keep Up With Biologics Tech

By Eva Temkin and Jessica Greenbaum (September 15, 2023, 4:45 PM EDT) -- The U.S. Food and Drug Administration operates under two different statutory frameworks in its review and approval of drugs: Section 505 of the Federal Food, Drug and Cosmetic Act governs drugs that do not fit within the definition of "biological product," while Section 351 of the Public Health Service Act governs biologics....

Law360 is on it, so you are, too.

A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.

A Law360 subscription includes features such as

  • Daily newsletters
  • Expert analysis
  • Mobile app
  • Advanced search
  • Judge information
  • Real-time alerts
  • 450K+ searchable archived articles

And more!

Experience Law360 today with a free 7-day trial.

Start Free Trial

Already a subscriber? Click here to login

Related Sections

Law Firms

Government Agencies

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!