FDA Policy/General
Federal Register notice: FDA is announcing the withdrawal of a guidance entitled “Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID–19 Public Health Emergency.” The document was issued in 4/2020 to communicate a temporary policy regarding the repackaging or combining of propofol drug products. The
Drugs
A new JAMA research article says that between 2018 and 2021, FDA approved 210 new drugs and 21 (10.0%) were approved based on pivotal studies with “null findings for one or more primary efficacy endpoints.” The researchers, from Yale Medical Scholl and Brigham and Women’s Hospital, say their
Drugs
FDA has issued India’s Biocon Biologics a complete response letter on its BLA for a biosimilar version of bevacizumab (Genentech’s Avastin), which is indicated for treating six cancer types: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma;
Drugs
FDA has completed an inspection of a Laurus Labs formulations manufacturing facility (Visakhapatnam, Andhra Pradesh, India. The inspection was conducted 2/6-10 and resulted in a Form 483 with two undisclosed observations, a company release says, adding that they were “procedural in nature,” It says the observations will be
Devices
Johnson & Johnson’s Ethicon unit has reached an almost $10 million settlement agreement with Kentucky over alleged deceptive marketing practices involving the company’s pelvic mesh surgical devices. Under the terms of the agreement, Ethicon agreed to pay Kentucky $9.9 million within 30 days. “Patients suffer when medical
Drugs
FDA has published a draft guidance entitled “Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development” that provides a framework for neurodevelopmental evaluations that could be useful to assess long-term safety of a medical product intended for use in neonates. The document is focused on long-term evaluations
Drugs
FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 8 to 5 that GlaxoSmithKline’s proposals for two single-arm clinical trials of its Jemperli (dostarlimab) are sufficient to characterize its benefits and risks in the curative intent setting for patients with locally advanced, treatment-naïve, mismatch-repair deficient or
FDA Policy/General
FDA commissioner Robert Califf says that while new artificial intelligence (AI) advances are quickly becoming revolutionary and transformative, the agency is going to have to be flexible and learn as it goes because of the pace at which this is going. Speaking at a 2/10 Alliance for a Stronger
Devices
FDA has issued an emergency use authorization for the Cepheid Xpert Mpox test for use in a point-of-care setting for detecting monkeypox. “Validation data (were) gathered through the National Institutes of Health (NIH) Independent Test Assessment Program established as a collaboration between the FDA and the NIH,” the
Drugs
FDA has approved a Pfizer supplemental NDA for Cibinqo (abrocitinib), expanding its indication to include adolescents (12 to 18 years) with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. The drug
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of an Emergent Biosolutions supplemental NDA for Narcan (naloxone hydrochloride 2 mg/.1 ml) after the company requested it because it is no longer marketed. FDA says the action has no impact on the continued approval and marketing of Narcan nasal spray,
Drugs
A just-posted HHS “Covid-19 Public Health Emergency Transition Roadmap” says FDA and other agencies will continue to have “significant flexibilities and actions that will not be affected” as the Biden Administration transitions out of the current public health emergency in May (see earlier story). The roadmap says the
Drugs
FDA has issued two complete response letters to Phathom Pharmaceuticals — one for an NDA for vonoprazan for treating erosive esophagitis, and the other for a post-approval supplement for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin). Phathom said both letters address specifications and controls for
Drugs
Ropes & Gray attorneys say FDA will publish a notice in the Federal Register explaining the effect the HHS decision to terminate its Covid-19 public health emergency (PHE) on 5/11 will have on FDA guidances and enforcement policies. In an online post, the attorneys say that at the
Devices
FDA says the 12/19/22 GE Healthcare recall of its nuclear medicine system is Class 1. An agency notice says the company reported that a mitigation may not be correctly implemented, meaning that the detector could fail and lead to life-threatening bodily injury.
Drugs
Questions are being raised about Eiger BioPharmaceutical’s decision not to seek an FDA emergency use authorization (EUA) for its peginterferon lambda as a treatment for Covid-19. Bloomberg reports that a New England Journal of Medicine report found that those who were treated with Eiger’s therapeutic had a
Drugs
FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat preterm infants with retinopathy of prematurity (ROP). With this approval, the drug is now indicated to treat five retinal conditions caused by ocular angiogenesis. “Retinopathy of prematurity is a leading cause of childhood blindness worldwide,” the company says. “ Until now,
Devices
FDA has updated an ongoing safety communication on Philips Respironics ventilators, BiPAP machines, and CPAP machines to provide updated information about medical device reports (MDRs) that the agency received from 11/1/2022 to 12/31/2022. The devices have been associated with the breakdown or suspected breakdown of the
Devices
FDA has denied a petition filed in 2013 by Thomas Law Company on behalf of tort plaintiff Marteen Moore, who claimed injury caused by DuraSeal Spinal Sealant. The agency response says the device was approved via the PMA process and is indicated for use as an adjunct to sutured dural
Drugs
The Department of Justice (DoJ) has asked the 3rd Circuit Court of Appeals to reinstate conspiracy charges against KVK-Tech, a Newtown, PA, generic drug manufacturer. Courthouse News Service reports that in February 2022 a Pennsylvania federal court rejected the conspiracy charges, saying the government’s indictment failed to state
Drugs
FDA has revised its emergency guidance on compounding certain ibuprofen oral suspension products to address ongoing product shortages. Last month, FDA has issued an immediately-in-effect guidance on compounding certain ibuprofen products, which describes regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review periods for two drug products. The first is for Janssen’s Erleada (apalutamide), indicated for treating patients with non-metastatic castration-resistant prostate cancer. The regulatory review period is 2,795 days, of which 2,667