Devices
FDA has made available a draft guidance on “Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).” The document proposes the addition of several BPH treatment devices to a 2010 final guidance of the same name. Additionally,
FDA Policy/General
Federal Register notice. FDA has made available a final guidance entitled “Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients.” The document says that eligibility of a specific pediatric population for a cancer clinical trial should be considered when there is clinical evidence or a strong
Drugs
FDA has posted a drug safety-related labeling change for Eli Lilly and Incyte’s NDA for Olumiant (baricitinib 2mg), a once-daily oral drug for treating adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies.
FDA Policy/General
FDA has approved Medtronic’s 200mm and 250mm lengths of its In.Pact Admiral Drug-Coated Balloon to treat long superficial femoral artery lesions in patients with peripheral artery disease. Approval was based on clinical data from the complex lesion imaging cohorts of the company’s In.PACT Global Study,
Drugs
FDA has approved a Mylan and Fujifilm Kyowa Kirin Biologics Co. BLA for Hulio (adalimumab-fkjp), a biosimilar to AbbVie’s Humira (adalimumab), for treating rheumatoid arthritis, juvenile idiopathic arthritis (four years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis, in both
Drugs
FDA has released four cancer clinical trial eligibility criteria guidances. A guide on “Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections” provides recommendations on the inclusion of patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV)
Drugs
FDA has approved an Allergan supplemental BLA for an expanded use for Botox (onabotulinumtoxinA) — treating spasticity in pediatric patients two years of age and older, including those with lower limb spasticity caused by cerebral palsy. Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles
Devices
FDA has cleared a Mim Software 510(k) for its deep learning auto-contouring software, Contour ProtégéAI. Contouring of the organs at risk is part of routine radiation therapy planning. “Auto-contouring is an ideal use case for deep learning algorithms because it is one of the most time-consuming
Devices
FDA has made available a draft guidance entitled “Select Updates for Peripheral Vascular Atherectomy Devices -Premarket Notification [510(k)] Submissions.” The document discusses software in atherectomy devices which may include a variety of functions ranging from ensuring that malfunctions that could be hazardous do not occur (e.g., cause injury,
FDA Policy/General
Federal Register notice: FDA is seeking consumer organizations interested in participating in selecting voting or nonvoting consumer representatives to serve on its advisory committees or panels. FDA is also requesting nominations for voting or nonvoting consumer representatives to serve on advisory committees or panels for which vacancies currently exist or
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection entitled “Generic Clearance for Data To Support Cross-Center Collaboration for Social Behavioral Sciences Associated With Disease Prevention, Treatment and the Safety, Efficacy, and Usage of FDA Regulated Products.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection entitled “Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials.” The proposed research will examine the impact of adding a disclosure about a secondary claim in DTC and healthcare professional-directed promotion in the
Devices
The Coalition for Healthcare AI says that a strong regulatory framework that ensures the safety, efficacy, and equity of healthcare artificial intelligence (AI) is essential to ensure patient safety and allow clinical deployment. In a letter commenting on the agency’s earlier public workshop on the evolving role of AI
Drugs
Washington Legal Foundation has submitted a comment to FDA supporting the citizen petition of the Coalition to Preserve Access to Pharmacogenomics (PGx) Information. The letter says FDA is running a suppression campaign that not only threatens the public health but also runs afoul of the Constitution. “By prohibiting clinical labs
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates the work FDA has done on advancing the inclusion of diverse populations, including racial and ethnic minorities, in clinical trials. Commenting to the agency docket on strategic priorities for the FDA Office of Minority Health and Health Equity, PhRMA says
FDA Policy/General
Federal Register notice: FDA has announced a 7/15 Cardiovascular and Renal Drugs Advisory Committee online meeting. Panel members are scheduled to discuss a Mallinckrodt Pharmaceuticals NDA for terlipressin, indicated for treating hepatorenal syndrome Type 1. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts to participate in periodic consultation meetings on reauthorizing the Prescription Drug User Fee Act (PDUFA). The user fee program expires 9/2022 and new legislation will be required for FDA to continue
Drugs
FDA has accepted for review Leo Pharma’s BLA for tralokinumab for treating adults with moderate to severe atopic dermatitis. A company statement says FDA has set a PDUFA target action date in the second quarter of 2021. Leo describes tralokinumab as a fully human monoclonal antibody that specifically neutralizes
Drugs
FDA has accepted for priority review an AstraZeneca supplemental NDA for Brilinta (ticagrelor) for reducing subsequent strokes in patients who experienced an acute ischemic stroke or transient ischemic attack. The user fee review action is expected in the fourth quarter. The submission is based on results from the Phase 3
Devices
FDA has cleared a Baxter International 510(k) for the AltaporeShape Bioactive Bone Graft, which is intended to enhance bone growth and help achieve fusion. The clearance was based on a 2019 prospective, open-label, non-randomized clinical study that evaluated 102 patients with degenerative disc disease, spondylolisthesis and spinal
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Health Care Providers’ Understanding of Opioid Analgesic Abuse Deterrent Formulations (ADF).” FDA has determined that systematic research is necessary to provide detailed and comprehensive evidence on which to base the agency’s ADF-related policy, regulatory, and
Drugs
The Delaware federal court has denied a defendant’s motion to dismiss a generic drug patent case, rejecting the argument that conversion of a Paragraph IV certification to a Paragraph III certification deprives the court of subject matter jurisdiction. Attorneys Charles Chevalier and Christine Gaddis (Gibbons) write in their firm’