JD Supra

New Draft Guidance Addresses FDA’s Records Access Authority for Cosmetics Under MoCRA

On January 21, the US Food and Drug Administration (FDA) issued a draft guidance clarifying the agency’s authority to access ...
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FDA’s 2025 Biosimilar Draft Guidance: Strategic Considerations for Clients and Counsel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.