FDA Regulations
12 stories related to this topic, newest first.
FDA Proposes Removing Gender References From Regulations
The U.S. Food and Drug Administration issued a proposed rule this week to remove references to “gender” from its regulations. The agency cited a 2025 executive order from President Trump directing emphasis on biological sex across federal policies. The change has raised questions…
The FederalistAppeals Court Pauses FDA Mail-Order Mifepristone Permissions in Louisiana Case
The U.S. Court of Appeals for the 5th Circuit granted Louisiana a stay that halts the Food and Drug Administration's mail-order distribution permissions for mifepristone. The decision follows a lawsuit citing state costs and health risks to women. The U.S. Supreme Court issued a…
NewsweekSupreme Court Temporarily Restores Mifepristone Access in Louisiana Case
The Supreme Court issued an emergency stay restoring nationwide mail and pharmacy access to the abortion pill mifepristone, following a Fifth Circuit ruling that restricted it. The case, brought by Louisiana, centers on standing issues and could force the Trump administration to…
shrm.orgSupreme Court Temporarily Restores FDA Rule on Mailed Abortion Pills
The U.S. Supreme Court issued a temporary stay on a lower court decision that blocked a federal rule allowing the abortion pill mifepristone to be mailed without an in-person doctor visit. Justice Samuel Alito granted the pause until May 11, 2026, giving time for responses in the…
manilatimes.netDrugmaker Asks Supreme Court to Review Mifepristone Mail-Order Limits
A pharmaceutical company producing the abortion pill mifepristone has appealed to the U.S. Supreme Court to block a federal appeals court ruling that prohibits mail-order distribution of the drug nationwide. The Fifth Circuit's decision restores in-person requirements for obtaini…
Drug Makers Ask Supreme Court to Review Abortion Pill Mail-Order Ruling
Pharmaceutical companies producing mifepristone have petitioned the U.S. Supreme Court to pause a federal appeals court ruling that temporarily blocks the drug's distribution by mail. The Fifth Circuit's Friday decision reinstated an in-person requirement for obtaining the aborti…
axios.comFifth Circuit Temporarily Blocks Mail-Order Mifepristone Access
A federal appeals court has blocked the mailing of the abortion pill mifepristone, ending pandemic-era rules and requiring in-person prescriptions. The ruling criticizes the FDA's handling of safety data and sides with pro-life states like Louisiana. The drug's manufacturer has a…
Nbc News5th Circuit Reinstates In-Person Dispensing Requirement for Mifepristone
The 5th U.S. Circuit Court of Appeals issued a unanimous ruling temporarily blocking the mailing of mifepristone prescriptions nationwide. Danco Laboratories filed an emergency application with the Supreme Court to lift the restriction. The decision reinstates in-person dispensin…
BBC NewsFifth Circuit Requires In-Person Dispensing of Mifepristone
A federal appeals court ruled that mifepristone must be distributed in person, overriding FDA mail regulations. The decision, stemming from a Louisiana lawsuit, prompted an emergency appeal to the Supreme Court by the drug's manufacturer. Separate developments include new student…
NprFifth Circuit Issues Temporary Nationwide Order on Mifepristone
A U.S. appeals court issued an order on May 1, 2026, pausing FDA rules that allowed mifepristone to be obtained by mail or telemedicine. The decision, stemming from a Louisiana lawsuit, requires in-person dispensing nationwide. Stakeholders on both sides reacted, with the case li…
upi.comU.S. Updates Hepatitis B Vaccine Guidelines to Target Newborns at Risk of Infection
A new U.S. policy limits hepatitis B vaccine recommendations at birth to babies at risk of neonatal infection. Separately, Intellia Therapeutics reported positive trial results for its CRISPR treatment, and federal regulators announced new pathways for device coverage and psyched…
asiaone.comPanel Discusses Illicit Vape Smuggling by Cartels and Chinese Entities
A panel of experts at a Daily Caller event described how Mexican cartels and Chinese manufacturers distribute illicit vapes in the U.S., bypassing FDA regulations. They highlighted health risks, including potential fentanyl contamination and past outbreaks like EVALI. The discuss…