Siemens Healthineers’ MRI Software Cleared
The software can be used with scanners made by Siemens or other manufacturers. Source: Devices & Diagnostics Letter
Smiths Medical Pulls Infusion Pumps, Citing Software Error
The company expects to release software updates late next year that will fix the problem. Source: Devices & Diagnostics Letter
Trump Criticizes FDA Delay of Convalescent Plasma EUA
President Trump is lashing out at the FDA’s decision to hold off issuing an Emergency Use Authorization (EUA) for using convalescent plasma to treat COVID-19 patients. Source: Devices & Diagnostics…
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…
Pfizer-BioNTech COVID-19 Vaccine Moves Into Pivotal Trial
Pfizer’s and BioNTech’s experimental COVID-19 vaccine BNT162b2 has been chosen for a phase 2/3 efficacy study of 9,000 participants following its success in a phase 1 trial. Source: Drug Industry…
FDA 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
DOJ 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…
Calls 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…
MHRA 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…
483 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
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