Devices
The Medical Device Innovation Consortium (MDIC) says it has formed a Working Group, sought by FDA, focusing on 5G-enabled health technologies. MDIC says working group stakeholders are subject matter experts and senior-level executives from medical device manufacturers, 5G network operators, 5G chipset and network equipment manufacturers, wireless service
Drugs
FDA has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11), the first drug for positron emission tomography imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer. The approval was granted to UCLA and the University of California, San Francisco. An agency statement says Ga 68
Devices
FDA says its review of the Industry Lab Diagnostic Partners Web site determined that the firm is offering a Covid-19 at-home sample collection kit that is considered a medical device that is being marketed without marketing approval, clearance, or authorization from the agency. An 11/20 Warning Letter
Devices
Baxter Healthcare is recalling its Sigma Spectrum Infusion Pumps with Master Drug Library (V6, V8) and the Baxter Spectrum IQ Infusion Systems with Dose IQ Safety Software (V9) because improper cleaning may lead to residue build-up or corrosion on the device. “If the device is running only on battery
Drugs
FDA has approved a Genentech supplemental BLA for Xolair (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. “With Xolair, we observed significantly reduced nasal polyps and congestion symptoms in adults who had nasal
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications. The document focuses on specific recommendations pertinent to gastric pH-dependent drug-drug interaction (DDI) assessments and describes the agency’s
FDA Policy/General
President Trump had his chief of staff Mark Meadows summon FDA commissioner Stephen Hahn to the White House 12/1 to learn why the agency has not approved or authorized the use of Covid-19 vaccines after promising data was recently reported on their efficacy. Despite the appearance of political
Devices
FDA has recognized A2LA, a non-governmental third-party accreditation body, as a participant in the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. With FDA recognition, A2LA will be able to assess testing laboratories seeking ASCA accreditation to perform a premarket assessment for medical device companies.
Drugs
Minerva Neurosciences says that following a meeting with FDA on the data package and readiness to support an NDA of its roluperidone to treat negative symptoms in schizophrenia, it is continuing its development and NDA activities. Minerva says it had asked the agency to confirm that data from a Phase
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. ForYou, Inc., Loris, SC (10/20): FDA inspected the firm 2/19-2/21 and found significant GMP violations for dietary supplements, among other citations. The agency says that
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 10/13 notice announcing a public meeting and requesting comments on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with their use in
FDA Policy/General
Federal Register notice: FDA has made available a final guidance for industry #242 entitled In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products. In-use stability testing is intended to establish a period of time during which a multiple-dose drug product may be
Drugs
FDA has made available a draft guidance on Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications. The document notes that elevated gastric pH by acid-reducing agents (ARAs) can affect the solubility and dissolution characteristics of ora lly administered drug
FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Barry J. Cadden from providing services in any capacity to a person that has an approved or pending drug product application. In 2017, Cadden was convicted on three counts of introduction of misbranded drugs into interstate commerce, among other charges,
Drugs
FDA has approved a Rhythm Pharmaceutical NDA for Imcivree (setmelanotide) for chronic weight management (weight loss and weight maintenance for at least one year) in patients six years and older with obesity due to three rare genetic conditions: pro-opiomelanocortin (POMC) deficiency, proprotein subtilisin/kexin type 1 (PCSK1) deficiency, and
Drugs
FDA has launched the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for novel drug development tool (DDT) developers. “ISTAND encourages development of DDTs that fall outside of the existing DDT qualification programs: biomarkers, clinical outcome assessments, and animal models for use under the Animal Rule,” an
Biologics
Moderna has filed an emergency use authorization (EUA) for its Covid-19 vaccine mRNA-1273 based on updated efficacy data showing 94.1% vaccine efficacy. The vaccine’s primary efficacy analysis was based on 196 Covid cases, of which 185 were observed in the placebo group versus 11 in the
Devices
FDA has approved a Profound Medical humanitarian device exemption to market Sonalleve for treating osteoid osteoma, a non-cancerous bone tumor that occurs most often in the long bones of the leg, such as the femur and tibia, of young children and adolescents. The condition causes a dull, aching pain
FDA Policy/General
Info Collection on Dietary Supplement GMPs Federal Register notice: FDA sends to OMB an information collection revision entitled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” 11/25/2020 Info Collection on Special Protocols Federal Register notice: FDA submits to
FDA Policy/General
Celgene has agreed to acquire Delinia Inc., a privately held biotechnology company developing novel therapeutics for autoimmune disease.The $300 million transaction expands Celgene’s inflammation and immunology pipeline through the acquisition of Delinia’s lead program, DEL106, a novel IL-2 mutein Fc fusion protein . The therapy is designed
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Qualification Process for Drug Development Tools. The process was mandated in the 21st Century Cures Act, which defined a three-stage qualification process for drug development tools. The guidance outlines the new qualification process and transparency requirements, and discusses
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA. The document describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) an ANDA for a