FDA Policy/General
Former 15-year FDAer Henry Miller, now an American Council on Science and Health distinguished fellow, says uncertainty rules as FDA awaits the confirmation of commissioner-designate Martin Makary. Writing in his personal Pundicity online blog, Miller says that while specific priorities for Trump 2.0 are not yet clear,
Devices
An FDA medical device early alert says the agency is aware that Calyxo has notified affected customers that its CVAC Aspiration Systems have updated instructions for use. The alert says Calyxo identified a new risk of injury during use of the system when patients have high viscosity fluid in the
Devices
FDA says the Baxter 2/5 recall of certain Spectrum infusion pumps is Class 1. An updated medical device early alert says the pumps were recalled due to the potential for missing motor mounting screws, which may have occurred during the servicing process. The company said the affected pumps should
Drugs
FDA has published a Federal Register notice with the OTC monograph drug facility fee rates under the OTC monograph drug user fee program for FY 2025, which started 10/1/2024 and runs to 9/30. The notice says the monograph drug facility fee is $37,556 and the contract
Drugs
FDA has issued Japan-based Seikagaku a complete response letter on its BLA for condoliase, a treatment that reduces leg pain associated with lumbar disc herniation. The company says the letter did not cite any clinical study-related efficacy or safety information, and no additional clinical studies are required. However,
Devices
IceCure Medical says FDA has delayed its review decision on the company’s de novo marketing authorization request for ProSense and its use in early-stage low-risk breast cancer with endocrine therapy. The decision was expected this quarter and now the company says it should be issued next quarter,
FDA Policy/General
FDA has granted PEP-Therapy an orphan drug designation for PEP-010 and its used for treating pancreatic cancer. PEP-010 is described by the company as a first-in-class bifunctional therapeutic peptide being evaluated in an ongoing Phase 1b clinical trial in combination with chemotherapy (paclitaxel or gemcitabine)
Devices
Becton, Dickinson is correcting software (Class 1 recall) for the BD Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter after receiving reports that customers running both may experience delayed system response and backlogging of automated programming requests (APRs). “After the delay, outdated APRs may upload to the Alaris
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of three Emergency Use Authorizations issued to Beckman Coulter for its Access SARS-CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II Covid-19 tests. The action is based on the company’s request because the
Drugs
A 9/9-9/17/2024 FDA inspection at the Aspen Pharmacare drug manufacturing facility in Korsten, Gqeberha, South Africa, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 2/24 Warning Letter says the specific violations were: * failure to establish laboratory controls
Drugs
FDA has accepted a BLA submitted by Dr. Reddy’s Laboratories and Alvotech for AVT03, developed by Alvotech as a biosimilar of Amgen’s Prolia (denosumab) and Xgeva (denosumab). A statement from the companies says AVT03 is a human monoclonal antibody and biosimilar candidate to Prolia, indicated to treat osteoporosis
Drugs
A 10/16-10/19/2023 FDA inspection at the Vegewax Candleworx drug manufacturing facility in Concord, Ontario, Canada, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 6/14/2024 Warning Letter says the specific violations were: * failure to test samples of
Devices
Smiths Medical has recalled (Class 1) its ProPort Plastic Venous Access System because the device’s plastic port housing and port reservoir may separate due to a manufacturing defect. According to a recall notice. FDA has determined that the defect is related to the firm’s process controls. Last month,
Drugs
The International Council for Harmonization (ICH) says two of its guidelines have reached Step 2b of the ICH process. The M11 updated technical specification document, incorporating comments received during the first public consultation, has entered the second round of public consultation, which will focus solely on the technical specification document.
FDA Policy/General
Federal Register notice: FDA is updating its publication “Modifications to the List of Recognized Standards, Recognition List Number: 063,” which contains modifications to the list of standards the agency recognizes for use in device premarket reviews. The publication is intended to assist manufacturers who elect to declare conformity with consensus
Drugs
FDA has granted Merck traditional approval for Keytruda (pembrolizumab) for use in combination with trastuzumab and chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (a combined positive score of 1 or higher)
Devices
FDA has cleared a bioMérieux 510(k) for the latest version of its Vitek Compact Pro for microorganism identification (ID) and antibiotic susceptibility testing (AST) to help diagnose infectious diseases and combat antimicrobial resistance. The device is designed to provide efficient workflows, and fast routine ID/AST results and microbiology
Drugs
Sarepta Therapeutics says that a young man with Duchenne muscular dystrophy (DMD) died following treatment with the company’s Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy for DMD patients. A company statement says the patient suffered acute liver failure. It says that acute liver injury is a known
Drugs
Two Harvard University researchers who compared regulator treatment of first-in-class drugs in the U.S. and Europe say regulators need to carefully balance flexibilities with rigorous assessments of evidence for the drugs. Writing in Health Affairs, the researchers say they investigated FDA approval data for 186 first-in-
Drugs
FDA has granted Nurix Therapeutics an orphan drug designation for bexobrutideg (NX-5948) and its use in treating Waldenström macroglobulinemia (WM). Bexobrutideg is described by the company as an orally bioavailable, brain-penetrant degrader of BTK which is being evaluated in an ongoing Phase 1a/b clinical trial in adults
Drugs
An FDA BIMO (bioresearch monitoring program) 4/8-4/19/2024 inspection of three clinical investigations conducted by Dr. Mehran Bahrami in Adventura, FL, found objectionable conditions that indicate he did not adhere to laws and regulations governing the conduct of clinical investigations and the protection of human subjects. A
Drugs
A 71/0-8/1/2024 FDA inspection at the Advanced Pharmaceutical Technology drug manufacturing facility in Elmsford, NY, found repeat significant violations of current good manufacturing practice (CGMP) regulations for combination products. A 3/14 Warning Letter says specific violations were: * failure to establish and follow appropriate written procedures