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FDA has issued draft guidance outlining updated current good manufacturing practice (CGMP) standards for medical gases, including oxygen, nitrogen, nitrous oxide, carbon dioxide, helium,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 The draft guidance, which revises a 2017 version, incorporates new rules codified in 21 CFR part 213 that specifically address the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FDA has issued a draft guidance, Cross-Center Master Files: Where to Submit, with recommendations for master file holders about to which Center a master file is to be submitted (1) that is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
FDA Policy/General
Health and Human Services secretary Robert F. Kennedy Jr. has privately discussed plans to scale back the operational role of FDA commissioner Marty Makary, including the possibility of appointing another official to run day-to-day operations while leaving Makary as a more ceremonial figure — a move that administration officials
FDA Policy/General
FDA commissioner Marty Makary and CBER director Vinay Prasad offered an unusually candid preview of upcoming agency reforms during an FDA Direct podcast focused on the appointment of longtime oncology regulator Rick Pazdur as CDER’s new director (see earlier story). The two officials described Pazdur — formerly head of the
FDA Policy/General
An Axios report examines growing criticism of recent FDA actions that are fueling uncertainty among drug developers and weakening public confidence in the agency. The article notes that top Trump-era health officials entered office arguing that the FDA lacked transparency, was overly influenced by industry, and failed to follow
FDA Policy/General
University of Chicago researchers say that while the federal government has proposed expanding direct-to-consumer ad oversight to include influencer partnerships and sponsored content, “effective oversight will be challenging because promotion is driven by thousands of individual creators rather than a few dozen companies.” Writing in a JAMA Research
FDA Policy/General
FDA has introduced a new regulatory framework — the “plausible mechanism pathway” — designed to speed approval of highly personalized therapies for rare genetic diseases, according to an 11/12 article published in The New England Journal of Medicine by CBER director Vinay Prasad and commissioner Marty Makary. The accelerated pathway aims
FDA Policy/General
An 11/19 MAHA Summit in Washington will bring together leaders and influencers of the Make America Health Again movement, according to an event schedule obtained by Politico. An online post says the gathering will hear from vice president JD Vance and HHS secretary Robert F. Kennedy, Jr. The summit
FDA Policy/General
FDA Matters president Steven Grossman says strong morale will be built at FDA based on a foundation of trust. After reviewing all that has battered the agency in the first year of President Trump’s second term, Grossman raises the question of whether FDA staff morale is primed to rebound
FDA Policy/General
Despite recent departures among its senior ranks and turmoil caused by the ongoing government shutdown, FDA remains robust, according to commissioner Marty Makary, who spoke at the Milken Institute’s 2025 Future of Health Summit 11/6. Makary emphasized a shift toward a more collaborative culture and outlined ambitious plans
Biologics
The 11/5 Medpage Investigative Roundup highlights key findings in a STAT report (subscription required) about chaos at CBER under the leadership of Center director Vinay Prasad. The report indicates that several CBER employees have filed human resources complaints about the director’s management style and practices. It says employees
FDA Policy/General
President Donald Trump and the White House have “total confidence” in FDA commissioner Marty Makary as he weathers yet another agency crisis with the abrupt departure of new CDER director George Tidmarsh, who was accused of official misconduct by a drug company. A Politico article quotes from an e-mail
FDA Policy/General
Sydnexis says its SYD-101, a proprietary 0.01% atropine formulation developed with enhanced ocular delivery characteristics and room-temperature stability to slow the progression of myopia in children, met both the primary and key secondary endpoints in the Phase 3 STAR trial. A company statement says treatment effects were
FDA Policy/General
Reflecting on the recent FDA turmoil over the resignation of CDER director George Tidmarsh, Axios questions how long industry can “tolerate an underperforming and dysfunctional FDA … before looking to other markets.” Tidmarsh resigned as controversy broke over comments he made on social media that were part of a lawsuit alleging
FDA Policy/General
Sen. Jim Banks (R-IN) is urging FDA to step up inspections of pharmaceutical manufacturing facilities abroad, citing persistent quality lapses and lagging oversight in countries that supply the majority of U.S. drug ingredients. In a 10/16 letter to FDA commissioner Marty Makary, Banks warned that “shoddy foreign