Drugs
The Government Accountability Office (GAO) says the National Institutes of Health (NIH) can do a better job of ensuring that recipients of funds for research and development of FDA-approved drugs acknowledge the government’s role in their work. Members of Congress asked GAO to review how NIH-funded biomedical
Drugs
Xortx Therapeutics says a meeting with FDA staff put it in a better position to move toward accelerated approval for its Xorlo to treat autosomal dominant polycystic kidney disease (ADPKD). A company statement says the meeting was held to discuss details of the accelerated approval process and a clinical trial
Devices
FDA has updated its Catalog of Regulatory Science Tools to Help Assess New Medical Devices by adding three new tools and updating five tools. An online post says the new tools are: * Additively Manufactured Mock Spine Cage Designs for Mechanical Performance Test Assessments: STL Set 1; * Lumbar Integrated Fixation Devices
FDA Policy/General
FDA commissioner Robert Califf says FDA needs improved operational readiness with its inspection oversight to be prepared for the next pandemic. Testifying 5/4 at a Senate hearing on reauthorizing the Pandemic and All-Hazards Preparedness Act (PAHPA), Califf shared agency lessons learned during Covid-19 and outlined critical authorities
Drugs
FDA and the Duke-Margolis Center for Health Policy have jointly announced a 6/7-8 public workshop on the agency’s Rare Disease Endpoint Advancement (RDEA) Pilot Program and novel endpoint development for rare disease drug development. The workshop will discuss: * The pilot program, including application process and required
FDA Policy/General
Federal Register notice: FDA has announced a 6/15 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the selection of strain(s) to be included in the Covid–19 vaccines for the 2023–2024 vaccination campaign (fall to winter). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has created a docket to receive public comments on the identification, assessment, and control of N-nitrosamine (nitrosamine) drug substance-related impurities (NDSRIs). The agency has identified scientific and regulatory considerations regarding NDSRIs, including areas that may benefit from collaborative efforts, and requests comments on the
Drugs
FDA has issued a complete response letter to Novo Nordisk for its concizumab anti-tissue factor pathway inhibitor antibody, asking for additional information related to the monitoring and dosing of patients to ensure that the product is administered as intended. FDA also wants more information on the manufacturing process. Company
Devices
FDA has issued a warning on SD Biosensor’s Pilot Covid-19 At-Home Tests, distributed by Roche Diagnostics, due to bacterial contamination concerns with its liquid solution. “Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test,
Drugs
FDA has issued a five-item Form FDA-483 after a 2/27-3/7 inspection of Rentschler Biopharma’s manufacturing facility in Baden-Wurttemberg, Germany found significant GMP deficiencies. For example, the inspection cited the firm’s procedures for preventing microbial contamination as being inadequate. Inspectors said the facility
Drugs
Buoyed by positive results from the Phase 3 TRAILBLAZER-ALZ 2 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease, Lilly says it anticipates a regulatory submission to FDA this quarter and will work with the agency to achieve the fastest
Biologics
FDA has approved a GlaxoSmithKline BLA for Arexvy (respiratory syncytial virus vaccine, adjuvanted), for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. “Older adults, in particular those with underlying health conditions, such as heart or lung disease or
Drugs
FDA has published the International Conference for Harmonization (ICH) Q9(R1) guidance, Quality Risk Management, to offer a systematic approach to quality risk management that leads to better, more informed, and timely decisions. The document says it specifically provides guidance on the principles and some of the tools of quality
FDA Policy/General
Federal Register notice: FDA is correcting a 4/24 notice entitled “Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches” because it contained an incorrect topic for discussion. The corrected topic now reads: “Science- and risk-based approaches for developing and assessing innovative technologies across platform products and
Drugs
FDA has published a guidance, Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022, with information for stakeholders on the agency’s implementation of PDUFA 7 changes to the user fee program. The document describes the types of user fees authorized by PDUFA 7, how FDA determines
Biologics
Reps. Lori Trahan (D-MA) and Dan Crenshaw (R-TX) say they are concerned about FDA’s pace for authorizing and approving updated Covid-19 therapeutics. In a 5/3 letter to FDA commissioner Robert Califf, the two say that while FDA has modernized its process in the past for
Biologics
The Biotechnology Innovation Organization (BIO) says the scope of an FDA draft guidance on considerations for the design and conduct of externally controlled trials for drugs and biologics “is rather narrow, excluding aggregate-level data as well as hybrid designs using external controls to augment a randomized trial.” The BIO
Devices
FDA has cleared a Nano-X Imaging 510(k) for its Nanox ARC, a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography in adult patients. The clearance also covers the company’s Nanox Cloud, a cloud-based infrastructure. The company
Devices
FDA has cleared a Casana 510(k) for the Heart Seat, a smart toilet seat for measuring heart rate and oxygen saturation (SpO2). The device is part of what the company calls its push for “effortless, integrated, and consistent in-home health monitoring.” Casana says it has also partnered with
Drugs
FDA has published the International Council for Harmonization M9 Biopharmaceutics Classification System-Based Biowaivers Questions and Answers guidance. The document has questions and answers covering the Introduction/Scope, Biopharmaceutics Classification of the Drug Substance, Eligibility of a Drug Product for a BCS-Based Biowaiver, and an annex with questions and
FDA Policy/General
Federal Register notice: FDA has announced a 6/8 Antimicrobial Drugs Advisory Committee meeting to discuss an AstraZeneca BLA for nirsevimab, a long-acting respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody for intramuscular use. The proposed indication is preventing RSV lower respiratory tract disease in neonates, infants and
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” The collection supports FDA regulations that establish minimum GMP requirements for supplements to ensure their quality, such as recordkeeping,