FDA Policy/General
Agios Pharmaceuticals says it plans to seek accelerated approval for mitapivat in sickle cell disease, following a pre-submission meeting with FDA. At the meeting, FDA advised the company to include a confirmatory clinical trial as part of an accelerated approval pathway submission. Agios says it has already submitted a
FDA Policy/General
FDA is seeking industry and public input on how to expand the use of digital health technologies (DHT) in clinical trials, as part of a broader push to modernize drug and biologic development and regulatory decision-making. DHTs — ranging from wearable sensors and smartphone apps to implantable or ingestible devices
FDA Policy/General
Scholar Rock has resubmitted its BLA for apitegromab, an investigational therapy for children and adults with Spinal Muscular Atrophy (SMA), following alignment with FDA on manufacturing and supply issues that previously delayed approval. The resubmission follows a 9/2025 complete response letter that cited inspection findings at a contract manufacturing
FDA Policy/General
An opinion piece published by The Washington Times’ editorial board is drawing attention to growing criticism of FDA commissioner Marty Makary, arguing that his agency leadership reflects ideology overtaking scientific judgment. The editorial takes aim at recent remarks by Makary and personnel decisions within the agency, raising concerns about their
FDA Policy/General
University of Southern California Price School of Public Policy associate professor Genevieve Kanter says policymakers should consider conflict of interest policies to be part of a broader strategy of building public trust by being more trustworthy as an agency. “This includes providing comprehensive scientific justification for decisions, being transparent about
FDA Policy/General
The Government Accountability Office (GAO) says FDA should publicly share information on how it determines whether advisory committee members have conflicts of interest. A GAO report says the agency does not make this information available currently because it has not finalized a required guidance on the matter more than 13
Biologics
A Heartland Institute online newsletter quotes several experts with differing opinions on why CBER director Vinay Prasad is leaving FDA for a second time. The post says that during his tenure, Prasad, in his dual role as CBER director and agency chief medical and scientific officer, “raised concerns about drugs
FDA Policy/General
A new study published in JAMA Network Open highlights growing public health concerns over prescription drug promotion by social media influencers. The systematic review found that influencer-driven marketing frequently spreads misinformation, benefits from weak regulatory oversight, and leverages personal storytelling to increase persuasiveness, often making it difficult for audiences
FDA Policy/General
A pair of public health experts is calling for sweeping reforms to improve FDA’s transparency, arguing that longstanding gaps in disclosure persist despite recent progress. In a Viewpoint published 3/18 in the Journal of the American Medical Association, Irene Ulrich of the Center for Science in the Public
FDA Policy/General
FDA has released an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and medical devices greater clarity on regulatory expectations while reinforcing flexibility in testing approaches. The document, “Pyrogen and Endotoxins Testing—Questions and Answers (Edition 2),” aims to address areas of persistent
FDA Policy/General
Attorneys Nathan Brown and Maddy Bolger (Akin) say regulated industries should assess and incorporate the FDA suggestions in a 3/9 draft guidance, Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection, into their form FDA-483 response practices and, in particular, their corrective and
FDA Policy/General
A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered guidance on vaccines and autism could endanger public health as measles cases climb nationwide. In a letter to HHS secretary Robert F. Kennedy Jr., senators including
FDA Policy/General
FDA has updated an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications, detailing administrative steps used during regulatory review. The document — Standard Operating Policy and Procedure (SOPP) 8401.2 Administrative Processing of BLA and NDA Supplements — provides guidance for staff on the administrative
FDA Policy/General
FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, issuing 303 Warning Letters to companies involved with drugs and biologics — up 59% from 190 letters in FY2024 — according to a new analysis from consulting firm Eliquent Life Sciences. The report, authored by regulatory experts Erin Hartmann
FDA Policy/General
Several emerging regulatory and enforcement developments at FDA are expected to have significant implications for pharmaceutical, medical device, and digital health companies in 2026, according to a new legal update from ArentFox Schiff. The report highlights intensifying FDA enforcement activity, evolving regulatory frameworks, and growing litigation risks tied to agency
FDA Policy/General
FDA commissioner Marty Makary says the artificial intelligence (AI) tools the agency has implemented have saved its 14,000 staffers some 17,000 hours of human work time in the measurement period the agency has assessed since implementation at the end of 6/2025. In an online interview with Healthcare
FDA Policy/General
FDA has launched its new FDA Adverse Event Monitoring System (AEMS), a searchable new platform for analyzing adverse event reports. An agency statement says AEMS “represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products.” According to FDA commissioner
FDA Policy/General
Newsweek says FDA “has faced an unusual convergence of political, scientific, legal and operational pressure in recent months, as it balances public health demands with intensifying scrutiny from the White House, Congress, industry and patient advocates.” The magazine details four major issues that it says have plagued the agency in
FDA Policy/General
The Institute for Safe Medicines says FDA, the Federal Trade Commission, and the Department of Justice should take immediate action against Hims & Hers for its Super Bowl ad that promoted unapproved compounded drug products. A 3/3 letter to FDA says the ad “contained a startling array of unsubstantiated
FDA Policy/General
Five Sidley attorneys say the FDA 9/2025 crackdown on direct-to-consumer (DTC) prescription drug ads has involved Warning and Untitled Letters that were issued to drug manufacturers that articulate positions that “raise significant constitutional, legal, and regulatory concerns.” Their legal update notes that a recent Untitled Letter directly
FDA Policy/General
Americans express significantly greater confidence in career scientists at federal health agencies than in the leaders who oversee them, according to a new national survey that also shows declining trust in the FDA and other federal health regulators over the past two years. The survey, released 3/5 by the
FDA Policy/General
FDA has issued a draft guidance outlining how drug manufacturers should respond to inspection findings documented in an FDA Form 483, urging companies to submit detailed remediation plans quickly and take a more systematic approach to correcting quality problems. The document describes best practices for responding to inspectional observations identified