Drugs
FDA says it is requiring sponsors of amphetamine and methylphenidate products used to treat attention deficit/hyperactivity disorder and other disorders to update and standardize their prescribing information to clearly inform patients, caregivers, and healthcare professionals of the risks associated with the medications. An online notice says the required updates
FDA Policy/General
Federal Register notice: FDA has announced a 6/16 Oncologic Drugs Advisory Committee meeting of its Pediatric Oncology Subcommittee that will discuss dosage optimization in children with cancer. Discussion topics include variability in pharmacokinetic and pharmacodynamic parameters by age and size, the need for age-appropriate formulations, potential for toxicities
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.” The document provides updated recommendations on testing to help pharmaceutical manufacturers, repackers, other suppliers, and
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of three emergency use authorizations (EUAs) for Covid-19 tests because they are no longer being manufactured or distributed in the U.S. The affected tests are: * Thermo Fisher Scientific’s OmniPATH Covid–19 Total Antibody ELISA Test * Detect’s Covid–19
Drugs
CDER director Patrizia Cavazzoni says the Center has published a discussion paper, Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products, to initiate a discussion with interested parties in the medical products development community on using artificial intelligence/machine learning (AI/ML) in drug and
Drugs
The FDA Cellular, Tissue, and Gene Therapies Advisory Committee meets 5/12 to consider a Sarepta BLA seeking accelerated approval for its SRP-9001 (delandistrogene moxeparvovec), an adeno-associated virus vector-based gene therapy product, to treat ambulatory patients with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the
Drugs
Sens. Debbie Stabenow (D-MI) and Tina Smith (D-MN) and Rep. Jamie Raskin (D-MD) have introduced the Pharmaceutical Research Transparency Act to “increase transparency and make drug companies disclose their research and development expenses.” A statement issued by Stabenow says the bill follows a Government Accountability Office report
Devices
An FDA update on the use of the Apyx Medical Renuvion/J-Plasma device for certain aesthetic procedures says the agency cleared the Renuvion APR handpiece for coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring on 4/27. The update says the labeling and training for the
Biologics
FDA has approved a Chiesi Global Rare Diseases and Protalix BioTherapeutics BLA for Elfabrio (pegunigalsidase alfa-iwxj) for treating adult patients with Fabry disease. The PEGylated enzyme replacement therapy (ERT) contains the recombinant human α–Galactosidase-A enzyme, which is expressed in a plant-cell culture that is designed to
Drugs
Advisory committee members 5/10 voted 17 to 0 to recommend the approval of a Laboratoire HRA Pharma NDA seeking a prescription-to-nonprescription switch of its Opill, a norgestrel tablet 0.075 mg oral contraceptive pill. Overwhelmingly, panel members dismissed FDA concerns outlined in a briefing document released in
Devices
FDA has cleared a Hubly Surgical 510(k) for the Hubly Drill and its use in making burr hole procedures safer and more efficient in any setting, according to Hubly. “A burr hole procedure is the prerequisite brain surgery for any time a physician needs to access the brain,” the
FDA Policy/General
FDA says it is working with the National Institute of Standards and Technology on a project to generate needed resources for researchers and companies creating innovative animal biotechnology products by using genome editing to alter the genome of animals. An agency announcement says genome editing technology has “revolutionized the ability
FDA Policy/General
Federal Register notice: FDA has determined for patent term extension purposes the regulatory review period for Somscan’s Detectnet (copper Cu-64 dotatate), a radioactive diagnostic agent indicated for use with positron emission tomography for localization of somatostatin receptor positive neuroendocrine tumors in adult patients. The regulatory review period is
Drugs
FDA has published an immediately effective guidance, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol, to alert drug manufacturers, compounders, repackers, and suppliers to the potential health hazard of glycerin and other high-risk
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Expanded Access to Investigational Drugs for Treatment Use.” The collection supports electronic Form FDA 3926 “Individual Patient Expanded Access Investigational New Drug Application (IND).” The form requires the completion of data fields that enable the agency to
Drugs
A 7/5-7/8/22 FDA inspection at Premier Nutra Pharma, in Carlsbad, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/9/22 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
The DC federal court says FDA correctly determined that Ipsen Biopharmaceuticals’ Somatuline Depot should be regulated as a drug rather than as a biologic. Ipsen had argued that the FDA decision was arbitrary, capricious, an abuse of discretion, and contrary to law. Ruling on cross motions for summary judgment filed
Devices
FDA has cleared a Cumulus Neuroscience 510(k) for its dry-sensor Cumulus EEG headset and its use for the remote acquisition, display, and storage of electroencephalograph (EEG) data. “The headset is available in four sizes and is easily self-applied in less than five minutes with guidance from the
Drugs
FDA has accepted for review a Genentech supplemental BLA for Vabysmo (faricimab-svoa) for treating macular edema following retinal vein occlusion. The submission is based on data from two Phase 3 studies (BALATON and COMINO) showing that the therapy provided early and sustained improvement in vision, which met the primary
Drugs
FDA has granted Acrivon Therapeutics two fast track designations for developing ACR-368 (prexasertib) in platinum-resistant ovarian cancer and endometrial cancer. The targeted DNA damage response inhibitor therapy is being studied in a multicenter, open-label, single arm Phase 2 clinical trial in patients with platinum-resistant ovarian cancer,
Devices
Three Hyman, Phelps & McNamara staffers, a medical device regulation expert and two attorneys, say a recent FDA draft guidance on predetermined change control plans (PCCP) for artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSF) is intended to reduce the need for prior FDA authorization of
Drugs
FDA has approved an expanded indication for AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure. A company statement says the approval was based on positive results from the Phase 3 DELIVER trial. Farxiga