FDA Policy/General
While many health policy experts have expressed concerns that FDA will suffer under the Supreme Court’s Loper Bright decision because judges will be interpreting scientific and health-related terms rather than deferring to FDA’s judgment, University of Missouri law professor Erika Lietzan thinks Loper Bright “may not be
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad for BeOne Medicines’ Brukinsa (zanubrutinib) capsules and tablets is false and misleading and thus misbrands the drug. A 5/12 Notice of Violation says the totality of claims and presentations made through visuals in the ad “misleadingly suggests
FDA Policy/General
The departure of FDA commissioner Marty Makary “comes as a positive move after a period of turmoil in the biotech sector, but until a permanent replacement is found, the industry could be under pressure, according to analysts and investors” who were interviewed for a Reuters analysis. The news service has
FDA Policy/General
FDA’s newly announced pilot program for one-day inspectional assessments (see earlier story) may signal a long-term shift toward faster, AI-assisted oversight of regulated facilities, according to an analysis published by law firm King & Spalding. FDA formally announced the pilot program on 5/6, though the
FDA Policy/General
FDA commissioner Marty Makary has resigned after a week of mounting speculation that the Trump Administration was preparing to remove him. The resignation follows several days of reports that President Trump had approved plans to dismiss Makary over conflicts involving flavored vape approvals, abortion-pill policy, vaccine oversight and broader
FDA Policy/General
FDA has issued updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis (TB) treatments, emphasizing the need for shorter, safer and more effective regimens as global drug resistance and HIV coinfection continue to complicate care. The guidance provides recommendations on trial design, safety evaluation and efficacy
FDA Policy/General
Eisai and Biogen say FDA has delayed by three months its decision on a subcutaneous starting-dose formulation of Alzheimer’s drug Leqembi (lecanemab) after the agency requested additional information during its review. The new review action target date for the supplemental BLA is 8/24. The application seeks approval
FDA Policy/General
A legal analysis published by Crowell & Moring says a proposed FDA pilot program on artificial intelligence in early-stage clinical trials could shape future agency expectations for how sponsors validate, document and oversee AI systems used in clinical research. In a Request for Information (RFI) issued this month, FDA
FDA Policy/General
President Trump is dismissing reports that say FDA commissioner Marty Makary will be asked to resign soon. Late Friday, Trump told reporters he knew nothing about Makary’s job being in jeopardy. The new week has brought no changes at the agency so far, and Makary continues to be authorizing
FDA Policy/General
President Trump has reportedly signed off on a plan to remove FDA commissioner Marty Makary from his post, according to multiple media reports published Friday, potentially setting up another major leadership shakeup at the agency less than 14 months into the Trump administration’s second term. The Wall Street Journal
FDA Policy/General
Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path toward resubmitting their BLA for tabelecleucel, an investigational T-cell therapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD). The companies recently held a Type A meeting with the
FDA Policy/General
FDA commissioner Marty Makary is reportedly in the White House’s crosshairs and could be removed from his post in the coming weeks as the Trump administration weighs a broader shakeup of key personnel, according to a 5/6 report published by journalist Rachael Bade on her Substack. Citing unnamed
FDA Policy/General
Pharmaceutical advertising experts joined the Food and Drug Law Institute’s annual conference in Washington, DC 5/6 to share their reactions to FDA’s dramatically altered enforcement approach toward prescription drug promotion since last fall, creating new uncertainty for industry as the agency ramps up scrutiny of direct-to-
FDA Policy/General
FDA has launched a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model and deploy inspection resources more efficiently. The initiative is intended to introduce shorter, targeted facility reviews designed to complement, rather than replace, the agency’s traditional, multi-day
FDA Policy/General
FDA is facing mounting internal strain and external criticism just over a year into commissioner Marty Makary’s tenure, according to accounts from agency staff, industry executives and policymakers, raising questions about leadership stability at the nation’s top drug regulator. Makary, initially viewed as a conventional and well-qualified
FDA Policy/General
FDA has issued an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for its drug Amvuttra. In the letter, CDER’s Office of Prescription Drug Promotion said the Amvuttra Web page overstated the drug’s survival benefit in patients with transthyretin amyloid cardiomyopathy
FDA Policy/General
The Pharmaceutical Research and Manufacturers of America (PhRMA) is urging FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and unclear expectations could hinder innovation in precision medicine. In formal comments submitted on the agency’s proposed “plausible mechanism” framework, PhRMA called for
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a YouTube video and Spanish-language TV ad for Bayer’s Nubeqa (darolutamide) tablets for oral use are misleading because they include claims and representations about the drug’s benefits but omit important risk information associated with it. A 4/28
FDA Policy/General
The U.S. House Appropriations Committee on Tuesday approved legislation to fund FDA for fiscal year 2027, advancing the measure to the full House after a largely party-line vote. The Agriculture/FDA spending bill cleared the committee 4/29 by a vote of 35–25, according to congressional materials.
FDA Policy/General
Purdue Pharma was sentenced 4/28 in federal court in Newark, NJ, to pay more than $5 billion in criminal penalties for its role in the U.S. opioid epidemic. The penalties include a $3.544 billion criminal fine and $2 billion in forfeiture, though up to $1.775 billion
FDA Policy/General
Insulet has recalled (Class 1) certain insulin pump components, warning that continued use could result in severe injury or death. The recall affects specific lots of the company’s Omnipod 5 Pods, a wearable device used to deliver insulin continuously for people with diabetes. According to an FDA notice, Insulet
FDA Policy/General
FDA is moving to modernize how clinical trials are conducted, unveiling a pair of proof-of-concept studies and outlining plans for a broader pilot program aimed at enabling real-time data sharing between sponsors and regulators. In a 4/28 announcement Tuesday, the agency says two early-stage “real-