FDA Policy/General
FDA has released a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The document applies to devices with cybersecurity considerations, including but not limited to those that have a device software function or that contain software (including firmware) or programmable logic, and it
FDA Policy/General
FDA deputy chief of staff Samuel Doran is the target of an HHS Office of Inspector General (OIG) ethics investigation on whether he misled the federal government by using a sham divorce to conceal potential conflicts of interest, according to a Bloomberg report. At issue is the relationship between Doran
FDA Policy/General
The current climate at FDA is unprecedented in terms of the depth and breadth of its politicization. That’s the view of University of Southern California economist and associate professor of public policy Genevieve Kanter in an online interview with PharmaVoice. She says that while all presidential administrations use appointed
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad for ARS Pharmaceutical’s Neffy (epinephrine nasal spray) is false and misleading. A 1/23 Untitled Letter says the agency is concerned that it raised similar issues in a 9/9/2025 Untitled Letter and asked the company
FDA Policy/General
The year 2025 marked a period of significant transformation in FDA and Department of Justice (DoJ) enforcement activities. While traditional priorities around product quality, safety, and clinical research integrity remained central, the enforcement landscape increasingly reflected the current administration’s policy objectives, workforce restructuring, and evolving legal frameworks. A Ropes
FDA Policy/General
U.S., U.K. and Canadian drug regulators are announcing a 6/2-4 joint international symposium to discuss evolving regulatory expectations for clinical trials, bioequivalence studies and pharmacovigilance, according to a meeting notice posted by FDA. The three-day FDA/MHRA/Health Canada Symposium is expected to draw regulators,
Drugs
Six King & Spalding attorneys say the over 200 drug advertising and promotion enforcement letters FDA issued in 2025 hit a nearly-25-year high. Writing in an online blog post, the attorneys say the vast majority of the letters were issued after the agency’s 9/9/2025 announcement
FDA Policy/General
Former FDA Oncology Center for Excellence director Richard Pazdur is warning that political interference and internal upheaval are eroding the agency’s ability to function as a science-driven organization, according to public remarks delivered at a biotech industry gathering in San Francisco. He said the traditional firewall between scientific
FDA Policy/General
FDA’s latest enforcement action against a schizophrenia drug advertisement offers a pointed reminder of how narrowly the agency continues to interpret permissible direct-to-consumer claims, according to regulatory attorneys reviewing the case. A 12/15 Notice of Violation letter describes the TV ad produced by Bristol Myers Squibb’
FDA Policy/General
A new analysis from Harvard Law School argues that the U.S. drug regulator’s reliance on industry-paid user fees has left the agency vulnerable to both corporate influence and political interference, undermining the rigor of drug approvals and potentially putting patients at risk. In a blog post published
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer connected TV broadcast ad for Esperion Therapeutics’ Nexlizet (bempedoic acid and ezetimibe) tablets for oral use is false and misleading. A just-released 12/19/2025 Notice of Violation says the ad’s claims and presentations falsely
FDA Policy/General
These are the most substantive Warning Letters FDA issued in the last two weeks of December 2025. Darmerica. A 3/3-3/19/2025 FDA inspection at the Darmerica drug manufacturing facility in Davie, FL, found significant violations, including deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients
FDA Policy/General
Turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope after senior staff departures, internal disputes and controversial policy decisions ripple through the agency, raising concerns among public health experts and the biotech industry. The New York Times reports that the leadership strain spilled into the White House
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad produced by Bristol Myers Squibb’s Karuna Therapeutics unit for its Cobenfy (xanomeline and trospium chloride) capsules, for oral use, is false or misleading. A 12/15 Notice of Violation describes the ad and says its claims and
FDA Policy/General
Two Mintz attorneys say a recent FDA announcement that it has deployed agentic artificial intelligence (AI) raises concerns for regulated industries. Writing in their firm’s online newsletter, Joanne Hawana and Benjamin Zegarelli say agency officials predict that integrating agentic AI into regulatory workflows will lead to greater efficiency and
FDA Policy/General
House Republicans on the Energy and Commerce Committee on Wednesday blocked an effort by Democrats to compel HHS secretary Robert F. Kennedy Jr. to testify before Congress, as partisan tensions escalated over vaccine policy and the federal response to disease outbreaks. The failed subpoena vote came during a hearing of
FDA Policy/General
FDA commissioner Marty Makary sought to position himself as a supporter of vaccines while defending recent agency actions that have drawn scrutiny, including an internal memo on child deaths following Covid-19 vaccination and changes to hepatitis B vaccine recommendations for infants. In an interview with NPR, Makary said FDA
FDA Policy/General
FDA says it is removing a long-standing barrier to the use of real-world evidence (RWE) in regulatory reviews, signaling a significant shift in how the agency evaluates data submitted in drug and medical device applications. “In new guidance for certain types of medical device submissions, the agency states
FDA Policy/General
FDA has released two final guidances that provide recommendations to help clinical investigators comply with the safety reporting requirements for IND and IDE studies. The first guidance, “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices,” provides recommendations to help investigators identify drug-related serious adverse events that must be
FDA Policy/General
FDA is weighing changes to a long-standing labeling rule for dietary supplements and will temporarily exercise enforcement discretion as it evaluates industry requests to do so, the agency said in a 12/11 letter to industry. At issue is a requirement in 21 CFR 101.93(d) that mandates
FDA Policy/General
Two pharmacist-attorneys (BakerHostetler) are urging Congress to strengthen federal restrictions on how senior FDA officials move into private-sector roles, arguing that current post-employment rules have not kept pace with modern industry practices and have contributed to perceptions of regulatory capture. In a STAT News opinion piece, Lee
FDA Policy/General
FDA commissioner Marty Makary has alleged that the Biden administration failed to disclose internal data on myocarditis risks in young people following Covid-19 vaccination — a charge that federal health officials and former FDA leaders swiftly rejected as unfounded. In an interview with NBC News, Makary said an agency review