FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Cipla Limited, Mumbai, India (2/25): FDA inspected the company 9/2019 and cited significant GMP violations for finished pharmaceuticals. For example, Cipla failed to clean, maintain, and sterilize
Drugs
Novo Nordisk has halted two clinical trials in its concizumab Phase 3 development program (explorer 7 and 8) and one clinical trial in the Phase 2 program (explorer5) due to safety issues. The three trials were investigating concizumab prophylaxis treatment in hemophilia A and B patients regardless of inhibitor status.
Devices
FDA has added three questions to its Frequently Asked Questions document about the development of diagnostics for SARS-CoV-2 (generally known as coronavirus or Covid-19). The updated document includes answers to these new questions: * What laboratories are offering testing under the Policy for Diagnostic Tests for Coronavirus Disease-
Drugs
FDA has approved safety labeling changes to sodium glucose co-transporter-2 (SGLT2) inhibitors indicated to treat Type 2 diabetes. The changes recommend temporary discontinuation of the medications before a scheduled surgery. An agency online notice says that Janssen’s Invokana (canagliflozin), AstraZeneca’s Farixga (dapagliflozin), and Boehringer Ingelheim/Lilly’
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.” The document discusses the evidence necessary to demonstrate the effectiveness of investigational new drugs or
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled “Drug Products Labeled as Homeopathic” that appeared in the 10/25/2019 Federal Register. The extension allows interested parties additional time to submit comments., which must be done by 5/23. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Competitive Generic Therapies.” The document describes the process that applicants should follow to request designation of a drug as a competitive generic therapy (CGT) and the criteria for designating one. In addition, it includes information on the actions that
FDA Policy/General
Former FDA commissioner Scott Gottlieb says the U.S. will be in good shape for coronavirus testing by the end of the week. “Well, I think we're going to see a dramatic increase in diagnostic capability this week,” he said 3/15 on CBS’s Face the Nation.
FDA Policy/General
Federal Register notice: FDA has announced a 5/8 Cellular, Tissue, and Gene Therapies Advisory Committee meeting. Panel members will hear an overview and updates on research programs in the Tumor Vaccines and Biotechnology Branch and Cellular and Tissue Therapy Branch (Division of Cellular and Gene Therapies). To view the
FDA Policy/General
The U.S. government is warning that a 3/15 cyberattack against Health and Human Services’ computer systems was part of a disinformation campaign designed to disrupt the U.S. coronavirus response. The attack led to fake text messages being circulated that warn of a U.S.-wide quarantine being
Drugs
FDA has lifted a partial clinical hold against a Unum Therapeutics Phase 1 trial (ATTCK-20-03) involving ACTR707 in combination with rituximab in patients with CD20+ B cell non-Hodgkin lymphoma. The partial hold was initiated on 3/4 following the company’s submission of a safety report on
Devices
Within 24 hours of the sponsor’s request, FDA 3/13 issued the fourth coronavirus Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit diagnostic. “Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of
Drugs
FDA has approved an Endologix PMA Alto Abdominal Stent Graft System (Alto) for endovascular abdominal aortic aneurysm (AAA) repair. Approval was based on data from the ELEVATE clinical study. As part of the approval, the first 100 patients after commercial launch will be included in a post-approval imaging study
Drugs
Sen. Mark Warner (D-VA) has written HHS urging it to develop a long-term plan to move pharmaceutical manufacturing back to the U.S. to reduce reliance on foreign supply chains. “As the novel coronavirus (COVID-19) continues to spread globally, I write to convey my significant alarm over
FDA Policy/General
AmerisourceBergen has agreed to acquire independent drug wholesaler H. D. Smith for $815 million. Founded in 1954, H. D. Smith has 10 drug distribution centers across the U.S. It provides full-line distribution of brand, generic and specialty drugs. Orig3n, a Boston-based biotech, has acquired Interleukin Genetics’ CLIA
Drugs
FDA has published a final guidance on “Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Result From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.” The document discusses the evidence necessary to demonstrate the effectiveness of investigational new drugs or new drug uses intended
Devices
FDA has cleared a TransEnterix 510(k) for the Intelligent Surgical Unit (ISU) that enables “machine vision capabilities” on the Senhance Surgical System. The device is intended to assist in controlling laparoscopic instruments for “visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery,
FDA Policy/General
Federal Register notice: FDA has announced a 4/16 meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. Panel members are scheduled to review a TransMedics PMA for the TransMedics Organ Care System — Heart, a portable ex-vivo organ perfusion and monitoring system indicated for the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Biological Product Deviation Reporting for Blood and Plasma Establishments.” The document provides blood and plasma establishments with revised recommendations related to biological product deviation reporting. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an proposed information collection entitled “Requests for Nonbinding Feedback After Certain FDA Inspections of Device Establishments.” The collection supports a guidance under the same title that explains how the owner, operator, or agent in charge of a device establishment may submit a
Drugs
FDA has issued Roche Molecular Systems an emergency use authorization (EUA) for its cobas SARS-CoV-2 test for diagnosing coronavirus (COVID-19). The EUA was granted within 24 hours after receiving the application from the company, an FDA release says. “To expedite access to this test, FDA did not
Drugs
FDA has released the FDA-483 issued following a 12/2-12/20/19 inspection at Fusion IV Pharmaceuticals (Axia Pharmaceutical), a Los Angeles, CA, producer of sterile drug products. The inspection observations were: * failing to maintain buildings used in the manufacture, processing, packing, or holding of drug products in