Drugs
FDA has granted HuidaGene Therapeutics a rare pediatric disease designation (RPDD) for HG004 and its use in treating inherited retinal disease caused by RPE65 mutations. Inherited retinal disease is described by the company as a group of rare blinding conditions caused by mutations in any 1 of more than 250
Drugs
FDA has granted traditional approval for Genentech’s Gavreto (pralsetinib) for treating adult patients with metastatic RET (rearranged during transfection) fusion-positive non-small cell lung cancer (NSCLC) as confirmed by an FDA-approved test. Pralsetinib had previously been granted accelerated approval 9/2020 for the NSCLC indication based on
Drugs
FDA has issued Galera Therapeutics a complete response letter (CRL) on an NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment. “In the CRL, the FDA communicated that the results from the Phase 3 ROMAN trial together
Devices
FDA has cleared a Curiteva 510(k) for the Navigation Instrument System for use with its Prodigy Pedicle Screw System and SI-Lution Sacroiliac Joint Fusion System. The company says it designed the instruments to integrate seamlessly with its navigation system that assists surgeons in locating anatomical structures during surgical
Drugs
Researchers at three universities who evaluated the evidence in 413 studies supporting 37 novel drugs approved by FDA in 2022 say the results “highlight a trend toward less rigorous standards for novel drug approvals that has evolved over the past few decades.” Writing in an open-access JAMA Network Open
Biologics
FDA and the International Pharmaceutical Regulators Program’s (IPRP) Biosimilars Working Group is hosting a 9/12-13 virtual workshop on “Increasing the Efficiency of Biosimilar Development Programs — Reevaluating the Need for Comparative Clinical Efficacy Studies.” An FDA notice says that the workshop’s public sessions will discuss the experience
Drugs
Three Morgan Lewis attorneys say an updated FDA draft guidance to implement the International Council for Harmonizations good clinical practice (GCP) guidelines is part of a series of agency documents demonstrating its interest in modernizing the guidelines to account for emerging technologies. An online post says FDA’s receptivity to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Good Laboratory Practice Requirements for Nonclinical Laboratory Studies — 21 CFR Part 58.” The collection supports agency regulations that require medical product manufacturers to adhere to good laboratory practices (GLPs) for nonclinical laboratory studies. The GLPs specify minimum
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Investigational New Drug Application Requirements.” The collection is being revised to include additional burdens associated with recommendations found in the guidance document entitled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1).” To view the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Devices; Device Tracking — 21 CFR Part 821.” Agency regulations give it the authority to require by order that a manufacturer adopt a method for tracking a Class 2 or 3 medical device if it meets safety
Drugs
FDA has warned six overseas over-the-counter drug manufacturers about significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished drugs. In each instance, based on a review of records requested from the companies and other information, the 8/3 Warning Letters cited these violations: * failing to conduct
Devices
CBER says it is now beginning a phased implementation of in-person industry meetings with device manufacturers. “At this time, CBER will limit in-person meetings to Submission Issue Requests,” according to an agency notice. Now that CBER staff have begun returning (post-pandemic) to work at its White Oak,
Drugs
The Biotechnology Innovation Organization (BIO) says it “applauds FDA for the issuance of a comprehensive and clear discussion paper on the use of artificial intelligence/machine learning (AI/ML) in drug development and supports FDA’s risk-based approach to the review, assessment, and regulation.” In a comment letter, BIO
Drugs
Novo Nordisk says its Wegovy (once-weekly subcutaneous semaglutide 2.4 mg) reduced the risk of major adverse cardiovascular events (MACE) by 20% in overweight or obese adults in the SELECT trial. A company statement says Wegovy met the trial’s primary objective by demonstrating a statistically significant and superior
Devices
FDA has approved a Boston Scientific PMA for the POLARx Cryoablation System for treating patients with paroxysmal atrial fibrillation (AF). The device features the POLARx FIT Cryoablation Balloon Catheter, which allows two balloon sizes – 28mm and 31mm – in one catheter. “The system addresses known limitations by reimagining existing cryoablation offerings,
Drugs
FDA has published a draft guidance, QTc Information in Human Prescription Drug and Biological Product Labeling, to assist applicants to incorporate QTc interval prolongation-related information in the labeling of non-antiarrhythmic human prescription drug and biological products. The document provides illustrative examples of the content and format of QTc
FDA Policy/General
Federal Register notice: FDA has determined that Cubist Pharmaceuticals’ Cubicin and Cubicin RF (daptomycin) powder for injection were not withdrawn due to any safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the products if all other legal and regulatory requirements are met. The drugs
FDA Policy/General
Federal Register notice: FDA is seeking comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances. The following six substances are under critical review by the WHO because it is believed they are clandestinely manufactured and a
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs).” The document provides a recommended framework for predicting the mutagenic and carcinogenic potential of NDSRIs that could be present in drug products and recommends acceptable intake limits for
Drugs
Drägerwerk has recalled its Dräger Carina Sub-Acute Care Ventilators due to the potential for contamination of the breathing gas with 1,3- Dichloropropan-2-ol, a constituent of the PE-PUR foam used for sound insulation. The company says testing “measured concentrations of 1,3-Dichloropropan- 2-ol above
Drugs
FDA has granted ABM Therapeutics an orphan drug designation for ABM-1310, a novel small molecule BRAF inhibitor for treating patients with glioblastoma (GBM) who have the BRAF V600 mutation. The company says the drug has BRAF-mutation selectivity, high water solubility, and high blood-brain barrier permeability. ABM-1310
Drugs
FDA has approved a Sage Therapeutics NDA for Zurzuvae (zuranolone), an oral drug for treating postpartum depression (PPD) in adults. “Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities,” an agency release says. The daily recommended