JD Supra

FDA’s Draft Guidance for Cosmetics Industry Explains Records-Access Authority During Inspections

The U.S. Food and Drug Administration (FDA) has issued a draft guidance reminding the cosmetics industry that the agency can access a variety ...
JD Supra

What FDA’s TEMPO Pilot and CMS’s ACCESS Model Mean for Medical Device Manufacturers

The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched two coordinated initiatives: the ...

FDA’s 2025 Biosimilar Draft Guidance: Strategic Considerations for Clients and Counsel

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...