Drugs
FDA says it is developing new processes to help identify drug postmarket safety issues. For example, the agency’s Sentinel Initiative is using the FDA Sentinel Innovation Center (IC), to test “machine learning and natural language processing technologies to more effectively access and integrate data in clinical narratives for safety
Devices
FDA has cleared a Baxter International 510(k) clearance for its Novum IQ large volume infusion pump (LVP) with Dose IQ safety software. “Adding LVP modality to the Novum IQ Infusion Platform – which includes Baxter’s syringe infusion pump (SYR) with Dose IQ safety software, powered by the IQ Enterprise
Drugs
FDA has approved AstraZeneca’s Voydeya (danicopan) as an add-on therapy to Ultomiris (ravulizumab) or Soliris (eculizumab) for treating extravascular hemolysis (EVH) ) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Danicopan is described as a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-
Biologics
Eisai has submitted a supplemental BLA for monthly Leqembi (lecanemab-irmb) intravenous maintenance dosing in Alzheimer’s disease (AD) patients with mild cognitive impairment or mild dementia stage of disease (early AD). The submission is based on modeling of observed data from the Phase 2 study (Study 201) and its
Drugs
FDA has released a final guidance entitled “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.” The document provides instructions for electronically submitting to FDA’s Adverse Event Reporting System (FAERS) expedited individual case safety reports (ICSRs) from IND-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” The document describes the electronic format sponsors will be required to use when they electronically submit IND safety reports that are required under 21 CFR 312.32(c)(1)(i)
Devices
FDA has cleared Abbott’s i-STAT TBI (traumatic brain injury) cartridge to be used with whole blood to assess patients with suspected concussion at the patient’s bedside within 15 minutes. Previously, tests to help assess TBI were only cleared for use with plasma or serum, requiring samples to
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA’s recent draft guidance titled “Potency Assurance for Cellular and Gene Therapy Products” needs additional specificity and considerations for particular development phases. “Accordingly, PhRMA recommends including additional detail regarding phase-appropriate implementation and how the guidance would be applied to different
Drugs
FDA has cleared an Otsuka Pharmaceutical and Click Therapeutics 510(k) for Rejoyn, a prescription digital therapeutic authorized for treating major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD who are on antidepressant medication. Rejoyn is intended to reduce MDD symptoms.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Animal Studies for Dental Bone Grafting Material Devices — Premarket Notification (510(k)) Submissions.” The document provides animal study design recommendations and information to include to support a 510(k) submission for dental bone grafting material devices. It is also
Devices
Thoratec has recalled (Class 1) its HeartMate Touch Communication System due to software design issues. The Touch application is intended to be loaded onto a tablet to provide a user interface with hardware/software platforms for supporting left ventricular assist device (LVAD) patients, according to Thoratec. The application also introduces
Drugs
FDA says its electronic Submission Template And Resource (eSTAR) system is now available for voluntary 513(g) requests for information sent to CDRH. 513(g) requests for information involve the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug,
Drugs
FDA has lifted a partial clinical hold against ProJenX and its Study PRO-101, a hybrid Phase 1 clinical trial evaluating prosetin — a first-in-class MAP4 kinase (MAP4K) inhibitor—in healthy volunteers and participants with amyotrophic lateral sclerosis (ALS). “The healthy volunteer portions of the trial have been completed,
Devices
FDA has approved Roche’s cobas malaria test for use on the cobas 6800/8800 Systems to aid healthcare professionals in reducing potential risks of patient infection from transfused blood products. The test provides a “highly sensitive and specific solution to help ensure that infected blood units are removed from
FDA Policy/General
On the heels of the U.S. Supreme Court’s 3/26 oral arguments in Danco Laboratories v. Alliance For Hippocratic Medicine that restricts distribution of the chemical abortion pill mifepristone (Danco’s Mifeprex), a new Axios/Ipsos poll finds that most Americans say they support FDA continuing to approve
Drugs
FDA has posted a final guidance entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” The document describes the electronic format sponsors will be required to use when they electronically submit IND safety reports for serious and unexpected suspected adverse reactions that are required under 21 CFR 312.32(
Drugs
FDA has extended by three months its review of an Applied Therapeutics NDA for govorestat (AT-007) for treating classic galactosemia. The agency review extension gives it additional time to review supplemental analyses of previously submitted data that had been provided by Applied in response to FDA’s routine information
Devices
FDA has published a draft guidance, Animal Studies for Dental Bone Grafting Material Devices—Premarket Notification (510(k)) Submissions, with recommendations for animal studies that may assist manufacturers in complying with some special controls for dental bone grafting material devices. The document says the device is a material that is
Drugs
FDA has approved Akebia Therapeutics’ Vafseo (vadadustat) tablets to treat anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. A company statement describes Vafseo as a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to
Drugs
Aldeyra Therapeutics says that following discussions with FDA, it will start a dry eye chamber clinical trial in the first half of 2024 in hopes of being able to resubmit its NDA for reproxalap to treat dry eye disease. “Contingent on positive results from the planned clinical trial,” a company
Drugs
FDA has released the form FDA-483 issued following a 12/2-12/20/2019 inspection at the Fusion IV Pharmaceuticals outsourcing facility doing business as Axia Pharmaceutical in Los Angeles, CA. The form contained these nine inspection observations: * buildings used in the manufacture, processing, packing, or holding of drug
Devices
The Accreditation Scheme for Conformity Assessment (ASCA) consolidated pilot final report issued by CDRH says the pilot, which began in 2020, “met and in some cases exceeded program expectations.” The report says that while the pilot called for the inclusion of five consensus standards, the program now includes 80 recognized