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 ...
JD Supra

Awash in Data? FDA Removes a Barrier in Real-World Evidence Generation

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major ...

FDA’s 2025 Biosimilar Draft Guidance: Strategic Considerations for Clients and Counsel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

ProPublica publishes unreleased data on the origins of generic prescription drugs

The post ProPublica Publishes Unreleased Data on the Origins of Generic Prescription Drugs appeared first on ProPublica.