Drugs
FDA has revised the emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir and ritonavir) to authorize state-licensed pharmacists to prescribe the Covid-19 treatment to eligible patients with certain limitations to ensure appropriate patient assessment and prescribing. An agency statement says that allowing pharmacists to prescribe Paxlovid could
Devices
FDA has given 510(k) clearance to a VideaHealth artificial intelligence (AI) algorithm that the company says can help dentists identify cavities in patient X-rays. Fierce Biotech says that company data submitted to FDA to support the clearance said the AI helped reduce the number of caries lesions dentists
Drugs
Two Covington & Burling attorneys say the Federal Food, Drug, and Cosmetic Act preemption provision for over-the-counter medications is “expansive. Although there are a few outlier cases in the food labeling context, courts have interpreted the preemption provision for OTC medications to mean what it says: state law
Drugs
A CDER Office of Pharmaceutical Quality (OPQ) self-audit comparing approved drug regulatory submissions that employ continuous manufacturing versus traditional batch processes has identified regulatory and patient advantages to continuous manufacturing. In a CDER podcast, OPQ deputy director Mahesh Ramanadham says the audit found that applications that used continuous manufacturing
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of Xellia Pharmaceuticals’ ANDA for bacitracin for injection, 50,000 units/vial, after the company requested it be withdrawn. The intramuscular antibiotic is used for treating infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug. The
Devices
Medtronic says it appreciates FDA's continued support for the Case for Quality Voluntary Improvement Program (VIP) with its “innovative approaches to facilitate continuous improvement above and beyond compliance.” Commenting on an agency draft guidance, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, Medtronic
Drugs
Intercept Pharmaceuticals says that based on results from the Phase 3 REGENERATE trial of its obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis, it will resubmit an NDA to FDA. The company received a 2020 complete response letter to its original NDA submission. An Intercept announcement
FDA Policy/General
Federal Register notice: FDA is seeking consumer organizations interested in participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels. The agency is also requesting nominations for voting and nonvoting consumer representatives to serve on advisory committees. To view the notice, click
Drugs
FDA is warning about a possible increased risk of death with the Secura Bio cancer drug Copiktra (duvelisib) compared to another medicine to treat leukemia and lymphoma. A Drug Safety Communication says the risk was seen in results from a clinical trial that also found Copiktra was associated with a
Devices
FDA has cleared a LiveMetric 510(k) for its LiveOne, a wrist-worn nano-sensor technology for monitoring blood pressure every 10 seconds to improve the care and treatment of people with hypertension and cardiovascular diseases. The device requires no external calibration and continuously extracts the pressure waveform out of
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Rhythm Pharmaceuticals’ Imcivree (setmelanotide acetate), indicated for chronic weight management in adult and pediatric patients six years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or
Drugs
FDA has issued AFT Pharmaceuticals a complete response letter on its NDA for Maxigesic IV, a combination of 1,000 mg paracetamol and 300 mg ibuprofen solution for infusion for treating post-operative pain. According to AFT’s development partner, Hyloris Pharmaceuticals, the letter took issue with the submission’s
Devices
Royal Philips has teamed up with Biodesix to add the results of Biodesix’s Nodify Lung blood-based lung nodule risk assessment testing into Philips Lung Cancer Orchestrator lung cancer patient management system. “The incorporation of proteomics data, along with the radiologic and patient history data currently used to determine
Biologics
Genmab says it will submit in the second half of this year a BLA for subcutaneous epcoritamab, an investigational bispecific antibody for treating patients with relapsed/refractory large B-cell lymphoma. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T
Devices
FDA has approved PreventionGenetics’ POMC/PCSK1/LEPR companion diagnostic genetic test for use with Rhythm Pharmaceuticals’ Imcivree (setmelanotide), indicated for chronic weight management in adult and pediatric patients six years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency. The need for a diagnostic test to
FDA Policy/General
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Monday, July 11. The next overnight email news bulletin from this site will be issued that evening.
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from Class 3 to Class 2 (special controls), subject to premarket notification. For such devices, FDA is also proposing a new device classification regulation with the name “computer-aided devices which provide
Drugs
Pfizer has submitted an NDA to FDA for Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to treat Covid-19 in both vaccinated and unvaccinated individuals at high risk for progression to serious illness from Covid-19, consistent with the current emergency use authorization. A company statement says final results
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled ‘‘Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” The document describes how stakeholders such as patients, caregivers, researchers, medical product developers and others, can collect and submit patient experience data and other relevant
Drugs
FDA has placed a partial clinical hold on a Sanofi Phase 3 trial of tolebrutinib for use in treating multiple sclerosis and myasthenia gravis. The partial clinical hold pauses new enrollments in the trial, the company says. The Sanofi statement says the agency's action was based on a
FDA Policy/General
Federal Register notice: FDA has determined that Janssen Pharmaceuticals’ Micronor (norethindrone tablets), indicated for preventing pregnancy, was not withdrawn for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference this product if all other legal and regulatory requirements are met. To view the notice,
Drugs
Five major drug companies have commented on and suggested changes to an FDA draft guidance on developing drugs to treat ulcerative colitis. Novartis says it finds the draft to be clear and helpful for the future development of drugs to treat ulcerative colitis and recommends some changes that may further