FDA Policy/General
Reps. Greg Murphy (R-NC), Angie Craig (D-MN), Nick Begich (R-AK), and Hillary Scholten (D-MI) have introduced the No Handouts for Drug Advertisements Act, a bill that would prohibit tax deductions for the annual $6 billion in expenses related to direct-to-consumer (DTC) advertising of prescription
FDA Policy/General
FDA has given BlackfinBio the green light to conduct a Phase 1/2 clinical trial of its novel adeno-associated virus gene therapy, BFB-101, in children with hereditary spastic paraplegia, Type 47 (SPG47). Previously, the agency awarded the company an orphan drug designation and rare pediatric disease designation for
FDA Policy/General
HHS secretary Robert F. Kennedy Jr. earlier this week vowed to restore FDA’s and other health agencies’ Freedom of Information Act (FOIA) offices that were gutted earlier this month under White House-mandated staff cuts. The removal of FOIA offices appeared to go against previous Kennedy promises of “radical
FDA Policy/General
FDA says its Electronic Submission Gateway Next Generation (ESG NextGen) went live on 4/14 and is ready to receive submissions. The previous ESG has been retired and is no longer available for submissions, a notice says. The notice says ESG NextGen is the agency’s modernized platform for securely
FDA Policy/General
Federal Register notice: FDA is seeking a limited number of drug manufacturing establishments to participate in the second year of its voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program and its use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). The voluntary program was developed
FDA Policy/General
FDA Matters founder Steven Grossman says enough has changed in the Trump administration since Martin Makary accepted the nomination to be FDA commissioner in 11/2024 that he is facing a situation in which the agency’s integrity and decision-making are at risk. Writing in his organization’s blog,
FDA Policy/General
FDA Office of Prescription Drug Promotion (OPDP) director Catherine Gray and deputy director Mark Askine have resigned after losing most their staff to Trump Administration reductions in force earlier this month, according to Politico’s AgencyIQ. HHS secretary Robert F. Kennedy Jr. , who is not a fan of direct-to-
FDA Policy/General
The Democratic Lieutenant Governors Association has written president Donald Trump urging him to support and safeguard the integrity of key federal science agencies like FDA, NIH and the CDC, among others, and asked that he promote evidence-based policymaking that strengthens public trust and protects America’s health and prosperity.
FDA Policy/General
The 9/18-9/19/2024 Global Summit on Regulatory Science was hosted by FDA with the theme “Is Regulatory Science Ready for Artificial Intelligence?” A report from the conference, published in the open-source NPJ Digital Medicine, includes 10 key principles for regulating artificial intelligence (AI) described by former
FDA Policy/General
Three CDER and Digital Health Center of Excellence staffers say advancing the use of digital health technologies (DHTs) is a priority for FDA. “We recommend engaging early with FDA when planning to integrate DHTs into a clinical investigation to design a trial that will provide meaningful results,” the three write
FDA Policy/General
FDA commissioner Marty Makary says the agency will be rolling out soon a new drug approval pathway for rare diseases and incurable conditions. In a 4/17 interview on the Megyn Kelly Show, Makary said the agency will be approving drugs based on a “plausible mechanism and on sort of
FDA Policy/General
An HHS leaked budget document circulating in Washington projects a 17% cut in FDA budget authority (BA) (non-user fee) expenditures in FY 2026 from the FY 2023 final consolidated appropriations act, according to an FDA Matters post by Steven Grossman. The post notes that the numbers are subject to
FDA Policy/General
FDA commissioner Marty Makary is announcing a new policy directive that limits those employed at regulated (e.g., pharmaceutical and medical device) companies from serving as official members on agency advisory committees. “As part of this effort, the agency will prioritize and elevate the role of patients and caregivers, strengthening
FDA Policy/General
Federal Register notice: FDA is rescheduling a previously planned joint meeting of its Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee. Panel members are scheduled to discuss the findings of completed postmarketing epidemiologic studies that examined the serious risks and predictors of misuse,
FDA Policy/General
FDA is advertising for contractors to replace the travel operations staff who were terminated from employment as part of an agency-wide reduction in force (RIF). Federal News Network reports that about a week after its employees were terminated, the agency began drafting a statement of work seeking contractors for
FDA Policy/General
Recent FDA layoffs are raising red flags across the drug and biologic industries as experts warn that diminished inspection capacity could slow drug approvals and challenge companies’ ability to maintain GMP compliance. Pre-approval inspections are likely to suffer from staff shortages, according to a Morgan Lewis legal update.
FDA Policy/General
FDA has approved an Argenx BLA for a new option for patients to self-inject Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for treating generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). Vyvgart Hytrulo is now approved as a 20-to-30-second subcutaneous injection administered
FDA Policy/General
In a further blow to FDA morale, a 4/11 address to the agency’s White Oak, MD staff by HHS secretary Robert F. Kennedy Jr. was filled with unusual statements about the “Deep State” and accusations about employees becoming industry “sock puppets.” The Kennedy address failed on all levels
FDA Policy/General
Hundreds of U.S. biomedical innovators and investors are urging the Senate to help restore critical FDA staff that were recently laid off so that institutional knowledge at the agency is not lost. In a 4/6 letter to senator Bill Cassidy (R-LA), the stakeholders say that having an
FDA Policy/General
Attorneys Sarah Wicks and Anne Walsh (Hyman, Phelps & McNamara) say the recent and drastic reduction in force at FDA “is quickly becoming an information bottleneck — one that threatens to erode the transparency that stakeholders rely on.” Writing in their firm’s FDA Law Blog, Wicks and Walsh say that
FDA Policy/General
FDA has decided to allow some product review staff and supervisors to resume working from home at least two days a week, the Associated Press reports in a story based on conversations with three anonymous agency staffers. The story says an email on the subject was sent on 4/8
FDA Policy/General
Rep. Jamie Raskin (D-MD) and other federal lawmakers from the state are asking for a meeting with FDA commissioner Martin Makary to discuss the impact of significant cuts to the agency’s workforce. The Baltimore Sun reports the lawmakers said in a letter that “entire offices were reportedly eliminated,