Archive for April 2020
AstraZeneca Tests Diabetes Drug as COVID-19 Treatment in Phase 3 Trial
AstraZeneca has begun a phase 3 clinical trial to evaluate its diabetes drug Farxiga (dapagliflozin) as a possible treatment for hospitalized COVID-19 patients. Source: Drug Industry Daily
Read MoreFDA Bans Electrical Stimulation Devices for Aggression and Self-Harm
The FDA issued a final rule banning electrical stimulation devices (ESDs) used to reduce aggressive or self-harming behavior, saying that better treatment options are now available. Source: The GMP Letter
Read MoreNeuroMetrix Ordered to Pay $4 Million for Deceptive Advertising
Under a settlement with the Federal Trade Commission, devicemaker NeuroMetrix agreed to pay at least $4 million and stop making deceptive claims that its Quell transcutaneous electrical nerve stimulation device treats pain throughout the body when placed below the knee. Source: The GMP Letter
Read More483 Roundup: FDA Cites Six Firms for Quality Failures
Six devicemakers drew the FDA’s attention for lax validations, CAPAs, training and other failures found during agency inspections. Source: The GMP Letter
Read MoreWarning Letter Roundup: FDA Warns Four Devicemakers
The FDA issued warning to four devicemakers for lax design controls, inaccurate labeling and other serious failures at their manufacturing facilities. Source: The GMP Letter
Read MoreFDA Eases Adverse Event Reporting Requirements During the Pandemic
The FDA announced in a new guidance that it does not plan to object to delays in adverse event reporting for medical products during the pandemic. Source: The GMP Letter
Read MoreHHS Gives Liability Cover for Coronavirus Countermeasures
HHS is providing immunity from legal liability for activities related to medical countermeasures against COVID-19. Source: The GMP Letter
Read MoreColorado Submits Its Drug Importation Plan for Approval
Colorado — one of five states with drug importation plans in the works — has submitted its plan for importing prescription drugs from Canada to HHS for approval. Source: Drug GMP Report
Read MoreTrump Invokes Wartime Legislation to Fight Coronavirus Outbreak
President Trump has invoked the Defense Production Act in response to the growing coronavirus pandemic, enabling the federal government to order private industry to manufacture emergency medical supplies. Source: Drug GMP Report
Read More483 Roundup: FDA Cites Five Firms for Quality Failures
FDA investigators found a wide range of GMP deficiencies during inspections of a Biocon facility in India and at four U.S. plants. Source: Drug GMP Report
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