Drugs
Denali Therapeutics says it is on track to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and its use in treating Mucopolysaccharidosis Type II (MPS II, aka Hunter syndrome). The company says its projection is based on feedback from the agency during a
Drugs
FDA has posted a guidance entitled “Bioresearch Monitoring Technical Conformance Guide — Technical Specifications Document” that provides current agency specifications, recommendations, and general considerations for preparing and submitting clinical study-level information, subject-level data line listings by clinical site, and a summary-level clinical site dataset. The submitted information is
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of a 2020 emergency use authorization (EUA) granted to Roche Molecular Systems for the cobas SARS-CoV–2 & Influenza A/B nucleic acid test for use on the cobas Liat System. The company has told the agency that it has ceased
FDA Policy/General
Federal Register notice: FDA is classifying intervertebral body graft containment devices into Class 2 (special controls). The action is based on a 2020 Spineology de novo classification request for the Spineology Interbody Fusion System. The classification describes the non-rigid implant as designed to contain the bone graft within its
Drugs
A 2/28-3/11 FDA Bioresearch Monitoring Program inspection at the Clinical Integrative Research Center of Atlanta operated by Dr. Julio Flamini in Atlanta, GA, found objectionable conditions related to two clinical investigations. An 8/20 Warning Letter says Flamini failed to ensure that the investigations were conducted according
Biologics
An FDA review of the Web site maintained by Mother Stem Institute in Coral Gables, FL, and records it submitted in response to an agency request, established that the firm recovers and processes adipose tissue from donors for autologous use as “stem cells.” An 8/20 Warning Letter says the
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that several of the statements and proposals in an FDA draft guidance on the Platform Technology Designation Program lack clarity or are inconsistent with the law. The PhRMA comment letter recommends that FDA: * not impose extra-statutory limits on
Drugs
Ali Pharmaceutical Manufacturing, a subsidiary of American Laboratories, is asking FDA to require AbbVie to correct what Ali says is the misbranding of an investigational product in a thyroid study. The Ali petition says AbbVie is not using Ali’s Armour Thyroid in a study “to assess the safety and
Devices
Politico says that while concern about FDA regulation of artificial intelligence (AI) tools in medicine is growing, there is no shortage of people with ideas for improving the regulation. An online column cites a study by University of North Carolina researchers who looked at 521 FDA-authorized AI medical devices
Drugs
FDA has released the form FDA-483 issued following a 3/13-3/22 inspection at the Otsuka Pharmaceutical Company’s Second Tokushima Factory, a drug product and sterile/non-sterile drug substance manufacturing facility in Tokushima, Japan. The form contains these five inspection observations: * failure to clean, maintain, and
Devices
FDA has cleared an Embecta 510(k) for its proprietary Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to manage diabetes, including Type 1 and Type 2. The device features a tubeless patch pump design with a 300-unit insulin reservoir, which was designed
FDA Policy/General
Federal Register notice: FDA is classifying neuromuscular tongue muscle stimulators and their use for reducing snoring and obstructive sleep apnea into Class 2 (special controls). The action is based on a 2020 de novo classification request from Signifier Medical Technologies for its eXciteOSA device. As part of the classification, FDA
Drugs
CDER and CBER are seeking input to help advance the agency’s model-informed drug development (MIDD) program. FDA has previously described MIDD as an umbrella term covering the “integration and application of statistical, biological, and pharmacological data in support of clinical trial design and quantitative decision making, and includes,
Biologics
A week after granting competitors Moderna and Pfizer marketing authorization for their updated monovalent Covid-19 mRNA vaccines, FDA has granted an emergency use authorization for an updated version of Novavax’s Covid-19 vaccine that more closely targets currently circulating variants to protect against serious Covid-19-related disease,
Biologics
FDA has approved an Emergent BioSolutions supplemental BLA for an expanded indication for ACAM2000, (smallpox and mpox vaccine, live) to include preventing mpox disease in individuals determined to be at high risk for mpox infection. The approval is based on previously available data showing that ACAM2000 is effective in protecting
Drugs
CellProthera says it has reached “alignment” with FDA on a planned pivotal Phase 3 trial design for its ProtheraCytes cell therapy after completing a recent IND meeting. “Building on a successful Phase 2 trial in the UK and France, CellProthera is moving into the final phase of clinical development for
FDA Policy/General
Federal Register notice: FDA is classifying certain digital therapy devices for attention deficit hyperactivity disorder (ADHD) into Class 2. The action is based on a 2020 de novo classification request by Akili Interactive Labs for its EndeavorRx device. The classification identifies these devices as software intended to provide therapy for
FDA Policy/General
Federal Register notice: FDA is announcing a minor technical modification to an alternative option that permits quarterly manufacturer reporting of certain device malfunction medical device reports in summary form — Voluntary Malfunction Summary Reporting Program. The modification applies to voluntary summary reports for reportable malfunction events that device makers become aware
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.” The document describes and clarifies the VMSR Program, including the agency’s approach to determining the eligibility of product codes for the program and the conditions for submitting medical device reports
Biologics
Johnson & Johnson has submitted a BLA for nipocalimab, indicated for treating people living with generalized myasthenia gravis (MG). The submission is based on data from the Phase 3 Vivacity-MG3 study that “showed that outcomes for a broad population of antibody-positive participants who received nipocalimab plus standard of
FDA Policy/General
FDA has published two revised guidances issued by the Veterinary International Conference on Harmonization dealing with the validation of analytical procedures in veterinary drug applications. The documents say the revisions replace those made available in 7/1999 and 10/2010 and update contact information, standard disclaimer language, and formatting. The
Drugs
FDA has cleared a Think Surgical 510(k) for using its TMini Miniature Robotic System with the GMK Sphere and SpheriKA Knee Systems from Medacta International under a collaboration agreement between the two companies. The two knee systems have been added to Think Surgical’s ID-HUB, what it calls