News & Analysis as of

Federal Food Drug and Cosmetic Act (FFDCA) Regulatory Agenda Food & Drug Regulations

Manatt, Phelps & Phillips, LLP

Congress Revisits Longstanding Debate Over FDA Regulation of Lab-Developed Tests

On March 21, 2024, the Health Subcommittee of the House Energy & Commerce Committee held a hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” In the wake of...more

Quarles & Brady LLP

FDA Releases Draft Interim Guidance on Bulk Drug Substances in Compounding Under Sections 503A and 503B of FDCA

Quarles & Brady LLP on

The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act...more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

Burns & Levinson LLP

CBD Update: After the Passage of the 2018 Farm Bill, Now What?

Burns & Levinson LLP on

Just months ago, the hemp industry seemed to be on a clear path to legal certainty when the 2018 Farm Bill was passed on December 20, 2018 (the “2018 Farm Bill”). Though the passage of the 2018 Farm Bill legalized the...more

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