Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (determined by an FDA-approved test) with disease progression after one or more prior lines of systemic therapy. Approval was based on data
Drugs
FDA has published a final guidance, Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations, to give sponsors information on the design of an appropriate nonclinical program for developing radiopharmaceuticals to treat cancer, also known as oncology therapeutic radiopharmaceuticals. The document also contains recommendations for certain aspects of product labeling. The
FDA Policy/General
Federal Register notice: FDA has set the prescription drug user fee rates for fiscal year 2020. They are: Application requiring clinical data ($2,942,965), application not requiring clinical data ($1,471,483); and program fee ($325,424). To view the notice, click here.
Devices
FDA has granted B. Braun Interventional Systems a breakthrough device designation for the SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty balloon catheter for treating coronary in-stent restenosis. SeQuent is the latest generation coronary drug-coated balloon catheter developed by B. Braun. The company says the designation is
Drugs
FDA has issued a draft guidance, Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers, with information for sponsors and nonclinical laboratory staff about the management and conduct of pathology peer review performed during good laboratory practice-compliant toxicology studies. “When conducted, pathology peer review should be well-documented,
Devices
FDA has issued a draft guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, with the agency’s recommendations on testing to assess the safety and compatibility of medical devices in the magnetic resonance environment. The document also has the recommended format for magnetic resonance
Drugs
FDA has issued a final guidance, Bacterial Vaginosis: Developing Drugs for Treatment, to assist sponsors in the overall development program and clinical trial designs to support development of topical and systemic drugs and biological products for treatment of bacterial vaginosis. The document focuses on considerations that are specific to bacterial
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “E8(R1) General Considerations for Clinical Studies.” The International Council for Harmonization document describes internationally accepted principles and practices for designing and conducting drug/biologic clinical studies. In addition, it addresses the types of clinical studies that may be
Devices
FDA and France’s Dassault Systèmes will extend their collaborative research agreement for five years with an aim to spur medical device innovation by enabling innovative, new product designs. The company says its 3DEXPERIENCE platform “will be used to develop a new digital tool to enable more efficient regulatory review
Drugs
FDA has expanded the approval for Leo Pharma’s Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. The agency also granted Enstilar Foam pediatric exclusivity, extending it by an additional six months to 12/
Drugs
Ultragenyx Pharmaceutical has submitted to FDA an NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation disorders (LC-FAOD), a group of genetic disorders in which the body is unable to convert long-chain fatty acids into energy. The submission is based on data from a Phase 2
FDA Policy/General
A CooperSurgical 30-second TV spot for its ParaGard intrauterine copper contraceptive makes false and misleading representations about the product’s risks, according to a 7/25 Untitled Letter from the CDER Office of Prescription Drug Promotion (OPDP). The letter says OPDP’s Bad Ad Program also received a complaint
Drugs
FDA has made available a draft guidance entitled “E8(R1) General Considerations for Clinical Studies.” The International Council for Harmonization document describes internationally accepted principles and practices for the design and conduct of clinical studies of drug and biologic products. In addition, it provides an overview of the types of
Drugs
FDA and HHS have published a Safe Importation Action Plan outlining two potential pathways to lay the foundation for the safe importation of certain drugs originally intended for foreign markets. An HHS statement says the plan outlines the pathways the Trump administration “intends to explore to allow safe importation of
Drugs
FDA has released the FDA-483 issued following a 7/15-7/19 inspection at the Cipla Virgonagar, India, active pharmaceutical ingredient (API) manufacturing site. The inspection observations were: * inadequate investigations into out-of-specification QC analytical results, related to finished API product quality failures; * failing to adequately design, install,
Drugs
FDA has approved a Bayer NDA for Nubeqa (darolutamide), an androgen receptor inhibitor for treating patients with non-metastatic castration-resistant prostate cancer. Approval is based on data from the Phase 3 ARAMIS trial evaluating Nubeqa plus androgen deprivation therapy (ADT), which demonstrated a significant improvement in the primary efficacy
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements” (OMB Control Number 0910-0661). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A” (OMB Control Number 0910-0458). FDA requires a manufacturer who holds the
Drugs
FDA has released the FDA-483 issued following a 7/8-7/12 inspection at the Dr. Reddy’s Laboratories Unit 2 active pharmaceutical ingredient (API) manufacturing facility in Andhra Pradesh, India. The inspection observations were: * investigations into product complaints and out-of-specification quality control analytical results, related to
Devices
FDA has cleared a PhysIQ 510(k) for use of the company’s algorithm to continuously determine respiration rate in ambulatory patients. The clearance adds to PhysIQ’s current portfolio of FDA-cleared cloud-based analytics, which also include heart rate, heart rate variability, atrial fibrillation detection, and a personalized
Drugs
FDA and the European Medicines Agency have published a report on their 11/26/18 workshop with stakeholders on support for quality development in early access approaches such as PRIME (priority medicines) and Breakthrough Therapy designation. “Experience to date has shown that applicants face challenges to complete quality and manufacturing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices: Current Good Manufacturing Practice Quality System Regulation — 21 CFR Part 820” (OMB Control Number 0910-0073). To view the notice, click here.