Devices
In a Regulatory Affairs Professional Society interview, outgoing FDA Digital Health Center of Excellence director Bakul Patel says the agency needs additional Congressional authorities for its digital health products pathway and other digital programs. In the online interview, he said the authorities FDA needs include being able to use real-
FDA Policy/General
Federal Register notice: FDA has determined that Pfizer’s Glucotrol (glipizide) tablets, 2.5 mg, were not withdrawn from sale due to safety or effectiveness reasons. The determination will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Glucotrol is
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Benefit-risk Considerations for Product Quality Assessments.” The document discusses how FDA assesses risks, sources of uncertainty, and possible mitigation strategies for a product quality-related issue and how those considerations inform FDA’s understanding of the potential effect
Drugs
An 8/5-9/16/21 FDA inspection at Brigham and Women’s Hospital, Boston, MA, found significant violations of current good manufacturing practice regulations for positron emission tomography drugs. A 4/11 Warning Letter says specific violations were: * the facilities are not adequate to ensure the prevention of equipment
Drugs
CDER says it has launched its new Accelerating Rare disease Cures (ARC) program to speed and increase the development of effective and safe treatment options addressing the unmet needs of patients with rare diseases. An online announcement says developing drugs for some 7,000 rare diseases and conditions can be
Drugs
Mesa Biotech has recalled (Class 1) its Accula SARS-CoV-2 Test because certain lots of the device have an increased risk of giving false positive results due to contamination at the manufacturing facility. False positive results could lead to further exposure of uninfected individuals to Covid-19, according to
Drugs
FDA says its review of a Web site maintained by inhousepharmacy.vu indicates the site introduces into interstate commerce domperidone drug products that are unapproved new drugs. A 5/4 Warning Letter says domperidone is not currently a legally marketed human drug and is not approved for sale in the
Devices
FDA is cautioning against the use of the Skippack Medical Lab (SML) SARS-CoV-2 Antigen rapid test. An agency notice says the test is not authorized, cleared, or approved by FDA for distribution or use in the United States because SML Distribution has not provided FDA with adequate data
Biologics
A staff report prepared for the House Committee on Oversight and Reform and the House Select Committee on the Coronavirus Crisis details manufacturing issues at the Emergent Biosolutions Bayview vaccine manufacturing facility that the report says wasted hundreds of millions of taxpayer dollars and affected the country’s ability to
Drugs
FDA has approved a new indication for Eli Lilly’s Olumiant (baricitinib) for treating Covid-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant is the first immunomodulatory treatment for Covid-19 to receive FDA approval, according to an agency
FDA Policy/General
Federal Register notice: FDA has announced that it is withdrawing approval of Bristol Myers Squibb’s (Celgene) peripheral T-cell lymphoma indication for Istodax (romidepsin) for injection because a required confirmatory trial failed to demonstrate the drug’s effectiveness for the indication. Istodax remains approved for treating patients with cutaneous
FDA Policy/General
Federal Register notice: FDA has announced a 6/8 Pharmacy Compounding Advisory Committee meeting. Panel members are scheduled to discuss four bulk drug substances that have been nominated to be included on the agency’s 503A Bulks List for drug compounding — ammonium tetrathiomolybdate, enclomiphene citrate, ferric subsulfate, and glutathione. To
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.” The document describes the program that uses third-party appraisals to guide device quality improvements. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Draft Guidance for Testosterone.” The document provides product-specific recommendations on the information and data needed to demonstrate bioequivalence to support ANDAs for testosterone pellets. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is revoking Bio-Rad Laboratories’ Emergency Use Authorization (EUA) for its Bio-Rad Reliance SARS–CoV–2/FluA/FluB RT – PCR Assay Kit, and Applied DNA Sciences’ EUA for the Linea Covid–19 Assay Kit. The agency says both devices are no longer being distributed. To
Drugs
FDA has released a draft guidance entitled “Benefit-Risk Considerations for Product Quality Assessments,” which describes the agency’s benefit-risk principles used when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted in NDAs/BLAs, in addition to other information (e.g., inspection findings) available
Devices
The International Medical Device Regulators Forum (IMDRF), of which FDA is a member, has released for comment a proposed guidance entitled “Principles and Practices for the Cybersecurity of Legacy Medical Devices.” The document is intended to supplement the group’s 2020 guidance on Principles and Practices for Medical Device Cybersecurity
Biologics
CBER director Peter Marks briefed the House Select Subcommittee on the Coronavirus Crisis 5/6 and denied news reports the agency was planning to delay authorizing Moderna’s Covid-19 vaccine for children under five years old so that it can be considered at the same time as Pfizer’s
Drugs
FDA has lifted a clinical hold on LogicBio Therapeutics’ Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with methylmalonic acidemia (MMA), a mutation in a gene called methylmalonyl-CoA mutase that prevents the body from properly processing certain fats and proteins. According to the company, four
FDA Policy/General
Diabetes Device Feasibility Studies Guidance 05/06/2022 Federal Register notice: FDA has made available a final guidance entitled “Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus.” The document’s scope applies to devices such
Drugs
Mustang Bio has entered into a lease agreement with the UMass Medicine Science Park in Worcester, MA for a manufacturing facility to support the clinical development and commercialization of the company’s chimeric antigen receptor engineered T cell technology. The facility is expected to be operational for the production of
FDA Policy/General
DEVICES FDA has cleared a Mesa Biotech 510(k) for its Accula Flu A/Flu B test for use on the company’s polymerase chain reaction testing platform, which is designed for point-of-care infectious disease diagnosis. The test provides a qualitative result in about 30 minutes. It is