FDA Policy/General
The Union of Concerned Scientists (UCS) is preparing to distribute an online survey to tens of thousands of federal scientists in seven agencies to assess the state of science in their agencies under the Biden administration. “Surveying federal scientists to hear directly from them about their experiences is one of
FDA Policy/General
For the second time in six months, an FDA advisory committee convened to discuss data on Amylyx’s amyotrophic lateral sclerosis (ALS; also known as Lou Gehrig's disease) drug AMX0035 (sodium phenylbutyrate and taurursodiol), but unlike the 3/30 near mixed vote that recommended against approving the therapy,
Drugs
The Department of Justice (DoJ) says Bayer has agreed to pay $40 million to resolve two whistleblower suits alleging violations of the False Claims Act in connection with the drugs Trasylol, Avelox, and Baycol. The whistleblower suits were filed and pursued for almost two decades by former Bayer marketing employee
FDA Policy/General
The 2022 Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science report highlights updates to the 2021 report. FDA commissioner Robert Califf says the updates make apparent “the incredible breadth and depth of FDA’s science base.” Califf writes in the report’s introduction that in addition to highlighting
FDA Policy/General
FDA says it is expanding its “whole-of-governments” approach to combating the entry of illicit health products into the U.S. An FDA Voices post by FDA assistant commissioner for criminal investigations Cathy Hermsen and FDA Europe Office director Ritu Nalubola says “the variety and scope of the illicit
FDA Policy/General
Federal Register notice: FDA is making available a revised draft guidance for industry entitled “Charging for Investigational Drugs Under an IND: Questions and Answers.” Since issuing a final guidance in 2016, FDA has received questions from stakeholders through the docket and in the form of communications with review divisions. The
FDA Policy/General
Federal Register notice: FDA has announced an 11/2-3 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. On 11/2, panel members will review and discuss CDER’s Quality Management Maturity program and its proposed rating system that will help incentivize drug manufacturers to adopt more mature quality management
FDA Policy/General
Three Harvard Medical School researchers say there are steps FDA could take to become more consistent in its use of advisory committees to increase public confidence in the agency’s regulatory processes. Writing in the New England Journal of Medicine, the researchers say advisory committees can do more than provide
FDA Policy/General
FDA commissioner Robert Califf says the gap between FDA clearance or approval of a medical product and use of the product to treat patients “should be filled by an invigorated clinical research system that generates evidence that patients, clinicians, and health systems need to make well-informed decisions.” Writing in
FDA Policy/General
Federal Register notice: FDA has announced a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss and vote on an Ipsen Biopharmaceuticals NDA for palovarotene capsules, indicated for preventing heterotopic ossification in adults and children with fibrodysplasia ossificans progressiva. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has posted a list of recent information collections that have been approved by OMB. They are: * Food Labeling: Notification Procedures for Statements on Dietary Supplements * Guidance for Reagents for Detection of Specific Novel Influenza A Viruses * Mitigation Strategies to Protect Food Against Intentional Adulteration * Tropical Disease
FDA Policy/General
National Institute of Allergy and Infectious Diseases (NIAID) director Anthony Fauci says he will be stepping down at the end of the year. Fauci, who also serves as chief medical advisor to president Joe Biden, says he is not retiring, rather pursuing the “next chapter of my career.” “Over the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Devices: Current Good Manufacturing Practice Quality System Regulation — 21 CFR Part 820” (OMB Control Number 0910-0073). The collection covers FDA requirements that medical devices conform to GMPs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Center for Devices and Radiological Health Appeals Processes” (OMB Control Number 0910-0738). The collection covers various processes by which appeals requests regarding review of decisions or actions by CDRH may be submitted to the agency. To
FDA Policy/General
FDA says the Covid-19 health emergency has provided insight into changing inspection activities to the extent it is initiating a new inspection planning system that will be more efficient, transparent, and adaptable to evolving needs. “This will help prioritize high-impact inspections such as those for facilities manufacturing Covid-
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations — Premarket Notification (510(k)) Submissions.” The labeling recommendations are intended to promote the safe and effective use of such products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.” The document addresses a manufacturer’s application for an assay that was previously cleared for use based on performance characteristics when used with a specified instrument to an
FDA Policy/General
Federal Register notice: FDA has announced a 10/6 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss the strain selection for influenza virus vaccines for the 2023 southern hemisphere influenza season. To view the notice, click here.
FDA Policy/General
Federal Register final rule: FDA is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, it defines OTC hearing aids and establishes applicable requirements; amends existing rules for consistency with the new OTC category; repeals
FDA Policy/General
[Report by Jim Dickinson] Amid rising anti-government rhetoric and threats from the far right fanned by supporters of former president Donald Trump, FDA commissioner Robert Califf tells FDA Webview he feels his agency is secure but alert to the menace of disinformation. In an 8/17 discussion with me,
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).” FDA says hearing aids and PSAPs both affect a user’s ability to hear sound, but the products have different intended uses, and are therefore subject to
FDA Policy/General
Federal Register notice: FDA has granted a 10/17-19 hearing request to review and vote on whether agency approval for Covis’ Makena (hydroxyprogesterone caproate injection) should be withdrawn. In 2011, FDA approved the NDA under the accelerated approval pathway for reducing the risk of preterm birth in women with