Drugs
The CDER Biomarker Qualification Program has responded positively to a C-Path Predictive Safety Testing Consortium/Duchenne Regulatory Science Consortium qualification plan for glutamate dehydrogenase (GLDH) as a safety biomarker for drug-induced liver injury. A C-Path statement says the two consortia “provided scientific evidence supporting the use of
Biologics
The four leading Democrats on the House Energy and Commerce Committee are asking FDA for information on its response to fraudulent Covid-19 antibody test scams occurring in the marketplace. In a 7/22 letter, the lawmakers say that last month the FBI warned that scammers are marketing fraudulent and/
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” The document outlines FDA’s current thinking on general quality considerations for developing drugs that contain cannabis and cannabis-derived compounds, and the calculation of percent delta-9 tetrahydrocannabinol
FDA Policy/General
Federal Register notice: FDA is announcing its support for use in regulatory submissions of the current version of the International Institute of Electrical and Electronics Engineers bioinformatics computations and analyses standard. The agency is updating its FDA Data Standards Catalog to include this standard for submitting high-throughput sequencing data
Drugs
A bipartisan group of 18 members of Congress is asking FDA to provide information on its “policies mandating that drug companies conduct testing on dogs to fulfill regulatory requirements.” Their 7/22 letter says the “lawmakers understand from recent reports that in these tests dogs, even small puppies, are made
Drugs
The FDA Oncology Center of Excellence (OCE) says that people with cancer are at an increased risk of more serious outcomes from Covid-19. In data analyzed with Synapse, OCE also found that there are inequities for Black Americans and those of lower socioeconomic means. “It’s imperative that we
Devices
FDA has cleared an Integra LifeSciences 510(k) for its Cusa Clarity Ultrasonic Surgical Aspirator System for use in neurosurgery for resection of tumors ranging from soft to firm consistencies, which includes removal of primary and secondary malignant and benign brain and spinal tumors. Cusa is an ultrasonically vibrating surgical
Devices
FDA has approved a Becton, Dickinson PMA supplement for an expanded version of its BD Onclarity Human Papillomavirus (HPV) Assay. The submission includes the expansion for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66
Drugs
FDA is evaluating several different tests that can simultaneously test for both the flu and Covid-19 as part of the preparation for fall and winter when the U.S. will likely face both, FDA commissioner Stephen Hahn told Fox Business 7/22. He said the combination tests will help
FDA Policy/General
Federal Register notice: FDA is publishing an order to exempt a list of Class 2 devices from premarket notification (510(k)) requirements, subject to certain limitations. The exemption from 510(k) is immediately in effect for the devices listed. To view the notice, click here.
Drugs
A 10/3-10/25/19 FDA inspection at Stason Pharmaceuticals, Irvine, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/8 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
A 12/16-12/20/19 FDA inspection at the Signa SA de CV facility in Toluca De Lerdo, Mexico, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 7/14 Warning Letter says the specific violation was failing to adequately investigate out-of-
Drugs
FDA says Centurion Medical Products, Williamston, MI, manufactures and distributes sterile convenience kits that have not been approved or cleared by FDA. A just-released 6/11 Warning Letter says the agency’s 8/5-8/20/19 and 11/21-11/1/19 inspections at two Centurion sites determined
FDA Policy/General
Federal Register notice: FDA has announced an 8/11 public meeting entitled “Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI.” The meeting will include a presentation from an independent third-party contractor about its assessment of FDA-sponsor communications during the IND stage of drug/
FDA Policy/General
Federal Register notice: FDA has announced an 8/13 Oncologic Drugs Advisory Committee meeting to review a Mesoblast BLA for Remestemcel-L (ex-vivo culture-expanded adult human mesenchymal stromal cells suspension for intravenous infusion). The product has a proposed indication for treating steroid-refractory acute graft-versus-host disease
Drugs
FDA has placed a Pieris Pharmaceuticals Phase 1 study of PRS-343 on partial clinical hold while the company conducts an additional in-use and compatibility study requested by the agency. Currently-enrolled patients may continue to receive treatment, the company says, but no new patients can be enrolled until
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders.” The document describes the processes available to mammography facilities to request additional review of an adverse appeals decision on
Drugs
FDA has published a draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, outlining the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. The document does not address the development of fully
Drugs
FDA issued 7/9 a second Funding Opportunity Announcement (FOA) as part of the agency’s Standard Core COAs and Endpoints Pilot Grant Program. CDER director of patient-focused drug development and program offer for the FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoint Pilot Grant Program Robyn Bent
Biologics
Executives from five drug companies told a House Energy and Commerce subcommittee that FDA is not easing regulatory standards for Covid-19 vaccines despite the pressure to get one or more approved quickly. The Hill reports that testifying were executives from Moderna, Janssen, Merck, AstraZeneca, and Pfizer. “We do believe
Devices
FDA has approved Boston Scientific’s Watchman FLX left atrial appendage closure device, indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy by permanently closing off the left atrial appendage. The company says the Watchman FLX is