FDA Policy/General
An FDA-conducted clinical trial has found that daily use of cannabidiol (CBD) at levels similar to those reported by consumers can cause elevated liver enzymes in otherwise healthy adults, raising fresh safety questions about the popular products. The study by CDER scientists is the first randomized, placebo-controlled trial
FDA Policy/General
A deeply-reported “groundbreaking” ProPublica analysis of HHS workplace statistics finds that 21% of FDA staff have left the agency, either through reductions in force or voluntary retirements and resignations. The report says HHS did not dispute its analysis and its conclusion that over 20,500 HHS employees are no
FDA Policy/General
More than 750 current and former HHS staffers have signed an 8/20 letter calling on HHS secretary Robert F. Kennedy, Jr., to “stop spreading inaccurate health information” in the wake of an 8/8 shooting at the Atlanta, GA, headquarters of the Centers for Disease Control. CNN reports that
FDA Policy/General
FDA has extended by 90 days its review of a Regenxbio’s BLA for RGX-121 (clemidsogene lanparvovec), an investigational gene therapy for Hunter syndrome, a rare and life-threatening genetic disorder. The agency’s extension pushes back the user fee review action target date from 11/9 to 2/
FDA Policy/General
Conflicts of interest among federal vaccine advisors had fallen to historic lows well before HHS secretary Robert F. Kennedy Jr. abruptly dismissed the Centers for Disease Control and Prevention’s vaccine advisory committee earlier this summer, according to new research from the USC Schaeffer Center for Health Policy & Economics.
FDA Policy/General
FDA Office of Privacy information specialist Elizabeth Booker Houston’s recent departure after five years at the agency has gone viral following her dramatic resignation announcement with a pointed message for the White House. The lawyer, public health professional, and stand-up comedian took to Instagram last weekend, according to
FDA Policy/General
Some FDA employees who received reduction-in-force (RIF) informational packets were given sensitive information about other employees as well as information about themselves. FedScoop reports it spoke to two agency employees who were affected by the RIF and said they knew of instances when fired workers received personally identifiable
FDA Policy/General
Infactory CEO Brooke Hartley Moy says she was not surprised when FDA’s internal artificial intelligence tool Elsa started producing fake research data. Interviewed for an online Cybernews report, Moy says AI models are still far from perfect and are known to hallucinate facts, oversimplify nuance, and generate confident nonsense.
Biologics
Former CBER deputy director Julie Tierney, who also served at one time as FDA chief of staff, has joined Leavitt Partners as a principal in the Washington, DC, office. The firm says that with over 25 years of experience in FDA law and policy, Tierney “helps life sciences companies, patient
FDA Policy/General
Right-wing activist and commentator Laura Loomer is now publicly criticizing FDA commissioner Marty Makary over recent comments surrounding the departure of CBER director Vinay Prasad, accusing Makary of undermining the authority of president Donald Trump and his top advisors. Her criticism of Makary in an 8/5 X post
FDA Policy/General
Former FDA chief of staff Elizabeth Jungman has joined law firm Hogan Lovells as a partner in its pharmaceuticals and biotechnology practice in the Washington, D.C. office. As chief of staff under Biden Administration commissioner Robert Califf, Jungman oversaw the day-to-day management of the agency and provided
FDA Policy/General
FDA has granted TransMedics Group conditional approval to begin its next-generation Organ Care System (OCS) ENHANCE heart trial. The trial is designed in two parts, according to the company, and will assess the capabilities of TransMedics’ proprietary heart technology. TransMedics says it's OCS platform is designed to
FDA Policy/General
HHS acting general counsel Sean Keveney has been appointed FDA’s new chief counsel. Most recently at HHS, Keveney led the Department’s work for the Trump Administration on “discrimination crackdowns” involving Harvard, Columbia, Brown and Duke and their alleged violations of Title VI of the Civil Rights Act of
Biologics
Based on conversations with four anonymous knowledgeable sources, Politico is reporting that President Donald Trump overruled FDA commissioner Martin Makary and HHS secretary Robert F. Kennedy, Jr., to insist that CBER director Vinay Prasad be removed from FDA. Prasad had come under attack from conservative presidential whisperer Laura Loomer, former
FDA Policy/General
Top House Democrats on the Energy and Commerce Committee are raising concerns over what they describe as a coordinated effort by the Trump Administration to restrict access to vaccines and undermine public trust in the nation’s immunization system. Two oversight letters sent to FDA commissioner Marty Makary and HHS
FDA Policy/General
FDA commissioner Martin Makary says that while he wants to speed patients’ access to needed drugs, he also wants to reduce the need for pharmaceuticals by addressing the root causes of diseases. In an interview with Yahoo Finance, Makary said he has been focused on ensuring quicker access to drugs,
FDA Policy/General
FDA has posted the following user fee rates for fiscal year 2026 (effective 10/1). They are: * Prescription drugs and biologics: $4.682 million for an application requiring clinical data. This is an 8.6% increase in the current fee. The annual program fee is $442,213, which is a
FDA Policy/General
U.S. Representative Richard Hudson (R-NC) is leading a group of bipartisan House lawmakers in sending a letter to FDA commissioner Marty Makary urging the agency to take immediate action against the rising threat of illegal, counterfeit anti-obesity medications entering the U.S. The counterfeit products, which include
FDA Policy/General
FDA commissioner Marty Makary has defended CBER director Vinay Prasad from an online attack by far-right influencer and Trump confidant Laura Loomer in which she called for his removal for being too left-wing. In an interview with Politico, Makary said Prasad does not have a “political bone” in
FDA Policy/General
Rep. Nikema Williams (D-GA) and three other legislators have introduced the Plain Prescription Prices Act that would require direct-to-consumer TV ads for prescription drugs to include a statement of the drug’s list price. In a statement, Williams says the legislation “will empower consumers to hold drug
FDA Policy/General
Former and current FDA employees who have used the agency’s new internal generative artificial intelligence (AI) tool Elsa report that it can’t be trusted. An online Gizmodo post says three employees told CNN that Elsa makes up nonexistent studies, something commonly referred to in AI as “hallucinating.” The
FDA Policy/General
FDA has released a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products that provides recommendations to industry on formal meetings between the agency and sponsors relating to the development and review of proposed biosimilar, including interchangeable, products. The document discusses good meeting management