On April 30, 2026, the U.S. Food and Drug Administration (FDA) announced a proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulk Drug Substances List (“503B Bulks List”)—finding no clinical need for outsourcing facilities to compound the three drugs from bulk substances absent a drug shortage.
On December 7, 2018, the U.S. Food and Drug Administration (“FDA”) published a proposed rule (“Proposed Rule”) that, if finalized, would clarify the de novo classification process for medical devices, including (1) the format and contents of a de novo request and (2) the criteria for accepting or denying a de novo request. FDA intends to “enhance regulatory clarity and predictability... [and] provide a regulatory framework that sets clear standards, expectations and processes for de novo classification” through this proposed rulemaking.[1]
FDA regulates medical ...
On October 2, 2018, FDA Commissioner Scott Gottlieb released a statement announcing new agency actions to further deter “gaming” of the generic drug approval process through the use of citizen petitions. Among these actions, the most significant was the issuance of a revised draft guidance on citizen petitions subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), published on the same day. The stated goal of this revision was to create a more efficient approach to 505(q) petitions and to allow the Agency to focus reviewer resources on scientific ...
Recent Updates
- Congressional Action on Health Care Cybersecurity: HISAA is Re-Introduced and the Health Care Cybersecurity and Resiliency Act Moves Forward
- DOJ Corporate Fraud Enforcement Memo: What Health Care Companies Need to Know Now
- Attorneys General of Three States File Two Sweeping Lawsuits Targeting Telehealth Abortion Providers and State Shield Laws
- RFI Seeks Input on Medicare Part D’s Pharmacy Contract Standards
- Proposed H.R. 10336 Would Balance Innovation, Access to Dietary Supplements—Yet Change the Definition