Drugs
The Biotechnology Innovation Organization (BIO) says it is committed to enhancing clinical trial diversity as part of its BIOEquality Agenda. In a response to an FDA 11/29-11/30/2023workshop on clinical trial diversity, BIO notes that under the FDA Omnibus Reform Act of 2022, the agency was required
Devices
GE Healthcare’s Datex-Ohmeda unit has recalled (Class 1) its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) after the company says it became aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860
Devices
Maquet Cardiovascular is recalling its Atrium Express Dry Suction Dry Seal Chest Drain in response to Nurse Assist LLC’s 11/2023 recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to sterility concerns. “If an Express chest drain is knocked over (device not
Drugs
Some 263 Democrat members of the House and Senate filed an amicus brief with the Supreme Court asking that lower court rulings restricting access to the abortion drug mifepristone be reversed. In a statement from the Senate Judiciary Committee, the Democrats say that at issue in the case are evidence-
Devices
Two days after Philips Respironics announced a consent decree (see story) where it would stop marketing its troubled ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, FDA is now announcing updated medical device reports and reports of death associated with the devices. According to the
FDA Policy/General
Federal Register notice: FDA is correcting a 12/21/2023 notice announcing the availability of a final guidance entitled “Development of Monoclonal Antibody Products Targeting SARS–CoV–2 for Emergency Use Authorization.” The notice was published with an incorrect docket number, which has now been corrected to read “Docket No.
Devices
CDRH director Jeffrey Shuren says the Center intends to start the reclassification process for most in vitro diagnostic medical devices (IVDs) from Class 3 (high risk) to Class 2 (moderate risk). In an online post, Shuren says that most of the tests to be reclassified are infectious disease and companion
Devices
Some 29 advocacy organizations are again calling on FDA to release a proposed ban on using electric skin shock devices to treat a person’s self-injurious or aggressive behavior. In a 1/23 letter circulated by the Autistic Self Advocacy Network, the groups say it has been eight years
Drugs
A 7/17-7/23/2023 FDA inspection at the S&J International Enterprises Public Company Limited drug manufacturing facility in Si Rachi, Thailand, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/26 Warning Letter says specific violations were: * failure of the
Drugs
The DC federal court has ordered FDA to either resolve a Vanda Pharmaceuticals sNDA for its Hetlioz (tasimelteon) to treat jet lag disorder or start a hearing on the sNDA on or before 3/5. The court’s ruling came as it granted Vanda summary judgment in its 9/2022
Drugs
FDA and the European Medicines Agency (EMA) will mark World Cancer Day with a 2/1 virtual public discussion spotlighting innovative cancer treatment advances for patients with chronic myeloid leukemia, multiple myeloma, and melanoma. An agency post says the program will run from 9:30 a.m. to 11 a.
Drugs
FDA has issued Defender Pharmaceuticals a complete response letter (CRL) on its NDA for intranasal scopolamine (DPI-386) for preventing nausea and vomiting induced by motion in adults. The company says it will request a formal meeting with FDA to “fully understand the issues raised in the CRL so we
Devices
Neuralink founder Elon Musk announced 1/29 that the company had implanted a chip in a human brain for the first time and that “initial results show promising neuron spike detection.” In a subsequent post on his social media platform X, Musk said Neuralink’s first product will be called
FDA Policy/General
Federal Register notice: FDA is announcing a 3/14 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Geron NDA for imetelstat for injection, indicated for treating transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes who have failed to respond or
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Human Gene Therapy Products Incorporating Human Genome Editing.” The document provides recommendations to sponsors developing human gene therapy products incorporating genome editing of human somatic cells. It also discusses the information that should be provided in an IND application
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” The document provides CAR T cell-specific recommendations regarding chemistry, manufacturing, and control, pharmacology and toxicology, and design of clinical studies for oncology indications (including hematologic malignancies
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.” The document provides recommendations on the use of a standardized approach for collecting and reporting race and ethnicity data in submissions including
Drugs
FDA has lifted a 2022-imposed clinical hold against INmune Bio’s XPro (XPro1595; pegipanermin) and its Alzheimer’s disease clinical trial. “The Phase 2 trial is on track to enroll the last patient mid-2024,” the company says, adding that top line data is expected about six months after
Drugs
The Department of Justice (DoJ) is looking at the use of artificial intelligence (AI) embedded in patient records that prompts doctors to recommend specific treatments. Bloomberg Law reports that department investigators want to learn more about generative technology’s role in facilitating anti-kickback and false claims violations. The newsletter
Biologics
FDA has accepted for priority review an AstraZeneca and Daiichi Sankyo supplemental BLA for Enhertu (trastuzumab deruxtecan) for treating adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior treatment or who have no satisfactory alternative treatment options. The submission is based on data from the
Biologics
FDA has posted a guidance entitled “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” The document provides recommendations regarding chemistry, manufacturing, and control, pharmacology and toxicology, and clinical study designs for oncology indications (including hematologic malignancies and solid tumors). It also provides recommendations for analytical comparability
Drugs
FDA has posted a draft guidance entitled “Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.” The document outlines FDA’s recommendations on using a standardized approach for collecting and reporting race and ethnicity data in submissions, including information collected and reported