Archive for August 2020
Merck’s Keytruda Improves Survival for Esophageal Cancer Patients
Merck said its blockbuster cancer drug Keytruda (pembrolizumab) in combination with chemotherapy significantly improved survival in patients with locally advanced or first-line metastatic esophageal cancer in a phase 3 clinical trial. Source: Drug Industry Daily
Read MoreDOJ Alleges Teva Illegally Used Charities for Copaxone Kickbacks
The Department of Justice has made another move against a drugmaker in its investigation of an alleged industry-wide kickback scheme, accusing Teva Pharmaceuticals of funneling kickbacks for its multiple sclerosis drug Copaxone (glatiramer acetate) through charitable foundations. Source: Drug Industry Daily
Read MoreFDA Loosens Requirements for Reserve Testing Samples
The FDA is easing its requirements for the amount of reserve samples that drug sponsors must retain for bioavailability and bioequivalence studies, citing improved testing methods. Source: Drug Industry Daily
Read MoreCalls for Urgent Reforms at MHRA Due to Safety Failings
An independent review of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has led to calls for major reforms at the agency due to its mishandling of safety concerns linked to pelvic mesh. Source: The GMP Letter
Read MoreMHRA Warns of Phony Compliance Certificates
The UK’s Medicines and Healthcare products Regulatory Agency is warning that certificates are being issued by certification bodies titled “certificates or compliance,” or “attestation of compliance,” that have no legal standing under the UK’s medical device regulations. Source: The GMP Letter
Read More483 Roundup: Four Firms Hit for Quality Lapses
FDA inspections at four U.S. facilities revealed problems with design controls, medical device reporting, and corrective and preventive actions. Source: The GMP Letter
Read MoreWarning Letter Roundup: FDA Warns Devicemakers for Unapproved Tests
The FDA issued warning letters to four device firms for violations that included unapproved tests and quality failures. Source: The GMP Letter
Read MoreTGA Reports Harm Caused by Medical Software
Australia’s TGA reported finding clear examples of harm caused by medical software in a review of medical device recalls. Source: The GMP Letter
Read MoreFDA Resumes Domestic Inspections Using New Risk Assessment System
FDA Commissioner Stephen Hahn said that the agency is resuming domestic inspections using a new risk assessment system developed in response to the pandemic. Source: The GMP Letter
Read MoreMedTech Europe Pushes for Virtual Audits Under MDR/IVDR
MedTech Europe is urging the European Commission and EU member states to publish guidance that clarifies that notified bodies may conduct audits virtually in place of on-site audits during the COVID-19 pandemic for new devices and in vitro diagnostics. Source: The GMP Letter
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