FDA regulation
29 stories related to this topic, newest first.
FDA Passes May Deadline Without Decision on Electrical Shock Devices at Judge Rotenberg Center
The Food and Drug Administration passed its self-imposed deadline without issuing a decision on whether to ban electrical shock devices used at one Massachusetts facility. Disability advocates and former residents continue to press for a ban.
The IndependentFDA Issues New Guidance Allowing Some Unauthorized Nicotine Products
The Food and Drug Administration published six-page guidelines earlier this month that permit certain nicotine products to remain on the market without full authorization. Senior staff in the agency's tobacco center learned of the changes the night before publication.
washingtonpost.comFDA Authorizes Blueberry and Mango Vape Flavors for Glas Products
The FDA approved the sale of blueberry- and mango-flavored vape juices made by Glas. The decision marks the first time the agency has authorized e-cigarette flavors other than tobacco and menthol.
abcnews.go.comSupreme Court Keeps Abortion Pill Available by Mail
The Supreme Court on May 14, 2026, granted emergency requests to block a May 1 ruling by the 5th U.S. Circuit Court of Appeals that would have restricted mail access to mifepristone. The decision ensures the drug remains available without an in-person clinician appointment while…
New York PostSupreme Court Allows Mail Delivery of Abortion Pill Mifepristone
The Supreme Court on Thursday maintained nationwide access to mifepristone by mail and telehealth, setting aside a lower court order that would have required in-person dispensing while a Louisiana lawsuit against the FDA continues. The unsigned order keeps in place FDA rules rela…
The IndependentUS Cancer Centers Report Surge in Requests for Experimental Pancreatic Cancer Drug
US cancer centers are seeing increased patient requests for daraxonrasib following positive clinical trial results that showed doubled survival rates for advanced pancreatic cancer. The FDA approved an expanded access program for the drug on 1 May, three weeks after the developer…
thestreet.comCompass Pathways Reports Positive Phase 3 Data for COMP360 in Treatment-Resistant Depression
Compass Pathways announced positive results from two Phase 3 trials of COMP360 for treatment-resistant depression during its first-quarter 2026 earnings call. The company has begun a rolling NDA submission with the FDA and received a Commissioner's National Priority Voucher. Offi…
StatFDA Medical Device Approval Pathway Examined in AI Newsletter
STAT's AI Prognosis newsletter published on May 13, 2026, reviewed the most common FDA medical device approval pathway and its characteristics. The edition also addressed sepsis algorithms and additional topics in health AI. Reporter Brittany Trang covers questions of whether AI…
washingtonpost.comFDA Authorizes First Fruit-Flavored E-Cigarettes for Adults
The U.S. Food and Drug Administration approved four new e-cigarette devices last week, including two with fruit flavors. Pediatrician groups and tobacco control organizations expressed concerns that the products could reach minors. The agency stated it continues to prioritize rem…
Washington ExaminerSupreme Court Extends Administrative Stay on 5th Circuit Mifepristone Ruling Through Thursday
The Supreme Court on Monday extended an administrative stay keeping mifepristone available nationwide by mail and through telehealth. Justice Samuel Alito pushed the deadline to at least 5 p.m. Thursday while the court weighs an emergency appeal from two manufacturers against a 5…
Nbc NewsEstrogen Patches Face Supply Issues as Demand for Hormone Therapy Rises
Doctors and patients have reported difficulties obtaining certain doses of estrogen patches used in hormone replacement therapy. The FDA removed a black box warning from such therapies in November 2025 and has not listed any estrogen patches on its official drug shortage list. Mu…
Military.comBipartisan Lawmakers Press FDA on Psychedelic Therapy Reviews After Trump Executive Order
Bipartisan letter initiated by Reps. Jack Bergman and Lou Correa presses FDA Commissioner Martin Makary for timelines and clarity on psychedelic and entactogen trials. The May 1 request follows President Donald Trump's April 18 executive order directing expanded access to ibogain…
StatSupreme Court to Act by End of Day on Mifepristone Restrictions Case
The Supreme Court must act by May 11 on emergency requests to maintain mail-order access to mifepristone or allow a lower court ruling reinstating in-person dispensing requirements to take effect. California abortion pill providers have readied workarounds using misoprostol alone…
Nbc NewsEstrogen Patch Demand Surges After FDA Removes HRT Black Box Warning, Prompting Supply Adjustments
The FDA removed the black box warning from hormone replacement therapies in November 2025, prompting a surge in demand that has strained supplies of estrogen patches. Multiple medical groups now list 14 brands or dosages in shortage while the FDA has not added them to its officia…
Washington ExaminerSupreme Court Extends Access to Abortion Pill Mifepristone Through Thursday
The Supreme Court on Monday extended an administrative stay allowing continued mail-order and telehealth prescriptions of mifepristone while it considers a challenge from Louisiana. Justice Samuel Alito issued the order, which prevents a 5th U.S. Circuit Court of Appeals ruling f…
Washington ExaminerSupreme Court Considers Emergency Appeal Over In-Person Requirement for Mifepristone
The Supreme Court is examining an emergency petition from two mifepristone manufacturers seeking to overturn a 5th Circuit ruling that restored an in-person screening requirement for the abortion pill. Anti-abortion groups and 23 Republican-led states urged the justices to keep t…
StatTrump Administration Announces Projected Savings From Drug Pricing Agreements
The Trump administration is touting massive projected savings from still-secret drug pricing deals even as outside experts question how independently verifiable the figures are. STAT reported on the claims alongside fresh accusations of political interference at the FDA, which wi…
cnbc.comSupreme Court Temporarily Blocks 5th Circuit Order on Mifepristone Telemedicine Rules
The Supreme Court issued an order signed by Justice Samuel Alito that blocks a 5th U.S. Circuit Court of Appeals ruling restricting access to the abortion pill. The stay keeps mifepristone available by mail or pharmacy without an in-person visit through at least Monday while the…
Los Angeles TimesSupreme Court Temporarily Blocks 5th Circuit Ruling on Mifepristone Telemedicine
The Supreme Court on May 5, 2026, placed a one-week hold on a 5th U.S. Circuit Court of Appeals decision blocking nationwide telemedicine prescriptions for mifepristone. Louisiana urged the justices to lift the hold while the Department of Justice filed no brief by the May 7 dead…
msnbc.comSupreme Court Grants One-Week Stay on Fifth Circuit Order Limiting Telehealth Prescriptions of Mifepristone
The Supreme Court stayed a Fifth Circuit order blocking nationwide mail and telemedicine prescriptions of mifepristone through May 11, 2026. Louisiana urged the justices to allow the restrictions, while nearly two dozen Democratic-led states and former FDA leaders filed briefs de…
Fox NewsSupreme Court Weighs Emergency Appeals Over Louisiana's In-Person Requirement for Mifepristone
Republican congressional leaders led by Sen. Bill Cassidy, Rep. Chris Smith, Senate Majority Leader John Thune and House Speaker Mike Johnson filed an amicus brief urging the Supreme Court to uphold the 5th U.S. Circuit Court of Appeals ruling reinstating in-person dispensing of…
cnbc.comSupreme Court Pauses Appeals Court Decision Reinstating In-Person Requirement for Mifepristone
The Supreme Court on Monday placed a one-week hold on a May 1 decision by the 5th U.S. Circuit Court of Appeals that had restored a requirement for in-person dispensing of mifepristone nationwide. The stay allows telemedicine prescriptions and mailing of the drug to continue at l…
New York PostFDA Authorizes First Fruit-Flavored E-Cigarettes for Adults From Los Angeles Company
The U.S. Food and Drug Administration on Tuesday authorized marketing of mango and blueberry e-cigarette pods along with menthol varieties from a Los Angeles-based manufacturer. The decision reverses the Biden administration's near-total rejection of flavored vaping products aime…
upi.comFDA Authorizes First Fruit-Flavored E-Cigarettes for Adult Smokers
The FDA on Tuesday authorized marketing of mango, blueberry and menthol e-cigarette pods made by Glas Inc. of Los Angeles, the first time regulators have cleared fruit-flavored vaping products. The decision follows industry appeals and a reported rebuke of the FDA commissioner by…
Nbc NewsExperimental Pancreatic Cancer Drug Doubles Survival in Advanced Cases
An experimental drug called daraxonrasib has shown it can double survival time for patients with advanced pancreatic cancer when combined with chemotherapy. The Food and Drug Administration has fast-tracked the drug for approval and allowed expanded access outside clinical trials…
fda.govFDA Advisory Committee Schedules July 2026 Review of Compounding Pharmacies' Peptide Production
An FDA advisory committee is scheduled to evaluate authorizing compounding pharmacies to produce certain injectable peptides in July 2026. This follows a March 2026 public meeting where peptide inclusion in oral dietary supplements was discussed. The moves come amid ongoing debat…
Substrate placeholder — needs reviewTechCrunch Podcast Covers BioticsAI's FDA Approval Path
TechCrunch's Build Mode podcast featured BioticsAI CEO Robhy Bustami discussing the company's journey from a $100,000 prototype to FDA clearance. The episode, released on April 30, 2026, covers challenges in medtech startups. Related events include TechCrunch Disrupt 2026 and a S…
Substrate placeholder — needs reviewGAO Report Details Disparity Between Illegal Vape Market Size and Enforcement Efforts
A Government Accountability Office report examines the scale of illegal e-cigarette products in the US and the federal response. The report identifies challenges in enforcement by agencies including the FDA and Justice Department. Anti-smoking groups have stated that stronger act…
NIH Image Gallery from Bethesda, Maryland, USA / Wikimedia (Public domain)Health Influencers Promote Unapproved Peptide Injections Amid FDA Oversight Concerns
Health and wellness influencers are promoting unapproved peptide injections through gray market channels. These treatments lack FDA approval and pose risks to consumer health. The trend raises questions about the agency's regulatory future.