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
FDA Policy/General
Writing in an online LinkedIn column, BoldApprovals managing director Steven Cohen makes the case that FDA advisory committees matter. “They make a real difference during the approval of a new treatment that has an impact at multiple levels, including public health, public policy, engagement, participation, trust, openness to the media,
Drugs
The CDER Office of Prescription Drug Promotion says a direct-to-consumer video for Daiichi Sankyo’s Turalio (pexidartinib) capsules, for oral use, is false or misleading and thus misbrands the drug. An 11/24 Notice of Violation describes the testimonial of a female patient with tenosynovial giant cell tumor
FDA Policy/General
A dozen former FDA commissioners have issued an extraordinary public warning this week, arguing that sweeping internal directives proposed by CBER director Vinay Prasad would undermine evidence-based vaccine regulation and threaten public health. In a New England Journal of Medicine Perspective, the former officials said a memo circulated last
FDA Policy/General
FDA has issued draft guidance outlining updated current good manufacturing practice (CGMP) standards for medical gases, including oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, and medical air. The draft guidance, which revises a 2017 version, incorporates new rules codified in 21 CFR part 213 that specifically address the
FDA Policy/General
FDA has issued a draft guidance, Cross-Center Master Files: Where to Submit, with recommendations for master file holders about to which Center a master file is to be submitted (1) that is referenced in and intended to support more than one regulatory submission for which the lead Center for
FDA Policy/General
National Center for Health Research president Diana Zuckerman says FDA commissioner Marty Makary’s plan to rely on “spontaneous [and] robust” expert panels rather than advisory committees misses the point on the value of advisory committees and undermines the credibility of agency decisions. Writing in a Medpage Today opinion column,
FDA Policy/General
A new analysis of nearly a decade of FDA advisory committee meetings reveals that a substantial portion of public speakers support drug approval — and many have financial conflicts of interest (COI), according to research published in JAMA Internal Medicine. Researchers from Mass General Brigham examined transcripts from 161 FDA human-
FDA Policy/General
The White House recently requested the resignation of a senior aide to FDA commissioner Marty Makary, highlighting growing friction between FDA leadership and Trump Administration senior staff. The aide, Sanjula Jain-Nagpal, had been slated for a promotion to deputy chief of staff, which Makary had advocated, but the White
FDA Policy/General
FDA has determined that a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) tablets is misleading and misbrands the drug. In a just-posted untitled letter, CDER Office of Prescription Drug Promotion (OPDP) takes issue with the ad, titled “Farxiga DTC TV: 45 – Places You Want to Be