Devices
A 7/23-8/9/2024 FDA inspection at Smiths Medical ASD, in Minneapolis, MN, which was acquired by ICU Medical in 1/2022, determined that the firm manufactures two infusion pumps that are adulterated because the company does not have an approved PMA or IDE for them and are
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,
Drugs
The International Council for Harmonization endorsed on 4/11 and released for public consultation the Q1 guidance Stability Testing of Drug Substances and Drug Products. The document outlines the stability data expectations for drug substances and drug products and applies to marketed drug products, including those associated with registration and
Drugs
FDA says it is aware of reports of adverse events involving compounded topical finasteride products potentially putting consumers at risk. An agency alert says FDA has approved two oral finasteride products for different indications — Organon’s Proscar and Propecia. “Currently, there is no FDA-approved topical formulation of finasteride,” it
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-
Devices
A 10/28-11/26/2024 FDA inspection at Noah Medical Corporation in San Jose, CA, found Quality System Regulation violations in the firm’s manufacturing of the Galaxy System bronchoscopes and accessories. A 4/9 Warning Letter says the specific violations were: * failure to establish and maintain procedures for
Drugs
AstraZeneca and Daiichi Sankyo are announcing interim data from the Phase 3 DESTINY-Breast09 trial that showed Enhertu (trastuzumab deruxtecan), in combination with Perjeta pertuzumab, significantly extended progression-free survival (PFS) compared to the current first-line standard of care (taxane, trastuzumab, and pertuzumab (THP)) in HER2-positive metastatic breast
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
Drugs
The 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 compliance with federal regulations. HHS laid off about 3,500 full-time FDA employees earlier this month, impacting key
Devices
Bard Access Systems, a Becton Dickinson subsidiary, has recalled (Class 1) its BD 4 Fr. Single Lumen PowerPICC Catheters due to tubing that exceeded melt flow index specifications, which could lead to increased material fatigue leaks. These leaks could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body
Devices
Q’Apel Medical is recalling (Class 1) and discontinuing the marketing of its 072 Aspiration System (also known under the product name “Hippo” and “Cheetah”) based on a recent Warning Letter that raised questions about whether the features and characteristics of the catheter’s distal tip were within the scope
Drugs
Researchers have published two articles on rare disease drug development in the Journal of Biopharmaceutical Statistics. The first discusses the role of regulatory flexibility in the review and approval process of rare disease drug development. It notes that this issue was recently studied by a National Academy of Sciences, Engineering,
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
Drugs
Exiger, a business consulting firm, says the U.S. drug supply chain “faces critical risks stemming from deep dependence on foreign drug manufacturers, complex geopolitical dynamics, and unethical international sourcing practices.” In a new white paper, “A Bitter Pill: America’s Dangerous Dependence on China-Made Pharmaceuticals,” Exiger cites these
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,
EIRs/483s
FDA has appointed Capitol Hill staffer Grace Graham as deputy commissioner for policy, legislation, and international affairs. In this capacity, she will head the agency’s Office of Policy, Legislation, and International Affairs, which serves as the focal point for engaging with Congress, the administration, global counterparts and partners, and
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