Biologics
FDA has published a guidance, Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development, with a framework for considering whether and what type of long-term neurologic, sensory, and developmental evaluations could be useful to support a determination of the safety of a drug, biological product, or
Drugs
FDA has informed Intercept Pharmaceuticals that the agency is continuing to review the company’s sNDA for full approval of Ocaliva (obeticholic acid, OCA) to treat indicated patients with primary biliary cholangitis. A company statement said FDA indicated that the original PDUFA action date of 10/15 has been delayed
Drugs
FDA has approved an AbbVie NDA for Vyalev (foscarbidopa and foslevodopa), which is described as the first subcutaneous 24-hour infusion of levodopa-based therapy for treating motor fluctuations in adults with advanced Parkinson's disease. In June, the agency had issued a second complete response letter (CRL) on
Drugs
FDA has released a draft guidance entitled “Postoperative Nausea and Vomiting: Developing Drugs for Prevention.” The document provides recommendations regarding the design of clinical trials for such drugs, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments. The agency notes that the guidance does not address
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a 9/23 notice about three draft guidance documents related to CDRH’s Accreditation Scheme for Conformity Assessment Program. Electronic or written comments can now be submitted until 12/23. To view the notice, click here.
Drugs
FDA is asking users of the NDA integrated review format that the agency started using several years ago to provide feedback on questions involving its usefulness. Attorney Deborah Livornese (Hyman, Phelps & McNamara) writes in a Pharmaceutical Online guest column that there are upsides and downsides to producing a leaner
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Requests for Reconsideration at the Division Level Under GDUFA.” The document provides recommendations on the procedures for ANDA applicants who choose to pursue a request for reconsideration within the review discipline at the division level or original signatory authority.
Drugs
Staska Pharmaceuticals has recalled (Class 1) one lot of ascorbic acid solution for injection (500mg/mL, 50mL vials) due to the presence of glass particulates in some vials. The product is used as a vitamin supplement. “The administration of an injectable product containing particulate matter may result in local irritation
Drugs
FDA has published a guidance, Core Patient-Reported Outcomes in Cancer Clinical Trials, with recommendations to sponsors for the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. The document says some of the recommendations may
Biologics
FDA has placed a clinical hold on Novavax’ IND for its Covid-19-influenza combination and standalone influenza vaccine candidates. A company statement says the hold is due to a spontaneous report of a serious adverse event of motor neuropathy in a single Covid/influenza combination Phase 2 trial participant
Drugs
FDA has published a guidance, Requests for Reconsideration at the Division Level Under GDUFA, with recommendations on the procedures for ANDA applicants that want to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. The document says such reconsideration requests should concern
Devices
FDA has cleared a Bracco Diagnostics and Subtle Medical 510(k) for their artificial intelligence-powered software AiMify for magnetic resonance imaging (MRI) of the brain. The software is designed to enhance brain MRIs, particularly detecting small and poorly enhanced lesions, the companies say. “AiMIFY leverages advanced AI technology to
Drugs
FDA has approved a Novocure PMA for Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for treating adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen. The portable device is designed to produce alternating electric
Drugs
The DC federal court has granted summary judgment to FDA and MSN Pharmaceuticals, the defendants in a suit filed by Novartis claiming the agency violated the Administrative Procedure Act, the Federal Food, Drug, and Cosmetic Act, and its implementing regulations by approving an MSN application to market a generic form
Drugs
FDA has accepted for priority review a GSK NDA for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for treating female adults and adolescents with uncomplicated urinary tract infections (uUTIs). The company says new treatments are needed as uUTIs caused by drug-resistant bacteria
FDA Policy/General
FDA commissioner Robert Califf and two agency colleagues say that historic advances in artificial intelligence (AI) applied to biomedicine and healthcare “must be matched by continuous complementary efforts to better understand how AI performs in the settings in which it is deployed.” Writing in a JAMA Special Communication, the authors
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Temporary Policies for Compounding Certain Parenteral Drug Products.” HHS has determined that public health emergencies now exist in the aftermath of hurricanes Helene and Milton based on reports from hospitals and health systems that they have experienced difficulties obtaining
Drugs
Jazz Pharmaceuticals says it will file a supplemental NDA next year following “positive top-line results” from its Phase 3 clinical trial evaluating Zepzelca (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Roche’s Tecentriq) compared to atezolizumab alone when administered as a maintenance treatment for adults with extensive-
Drugs
Writing in the CDER year-two annual report of its Accelerated Rare disease Cures (ARC) program, Center director Patrizia Cavazzoni says CDER partnered with CBER in 2023 to launch the Support for clinical Trials Advance Rare Disease Therapeutics (START) pilot program. The report says START offers selected participants enhanced communication
Drugs
FDA has posted seven things consumers should know about how CDER manages drug shortages. The items are: * the CDER Drug Shortage Staff (DSS) is the focal point for evaluating and managing drug shortages; * for many drugs, manufacturers must notify FDA about permanent discontinuances in manufacturing and manufacturing interruptions that are
Devices
CDRH is piloting medical device “trial participation snapshots” to provide “key information” about clinical trials that supported the agency’s approval of a new device. The pilot is part of the agency’s efforts to increase transparency around clinical trials and diversity in clinical trial participation. It is intended to
Devices
FDA has posted recommendations for preventing the risk of damage caused by electronic interference with wearable medical devices including wearable diabetes devices, cardiac implantable devices, and neurostimulators. “FDA has received some reports of electronic medical devices being damaged during CT scans,” the post says. “Damage to the devices may be