FDA Warns Bangalore Drugmaker for Contamination Investigations
A drug manufacturer in Bangalore, India, drew a warning letter from the FDA for failing to properly investigate contamination at its facility. Source: Drug GMP Report
Mylan API Plant Draws FDA Warning Letter
A Mylan Laboratories active pharmaceutical ingredient (API) manufacturing facility in India drew a warning letter from the FDA for cleaning and other failures. Source: Drug GMP Report
Las Vegas Compounder Warned for Poor Aseptic Practices
The FDA hit Las Vegas compounder ACRx Specialty Pharmacy for poor aseptic practices and other GMP failures observed during an inspection last year. Source: Drug GMP Report
Proposed Senate Bill Would Give FDA Drug Recall Authority
A new bill introduced by Sen. Gary Peters (D-Mich.) would give the FDA the authority to recall unsafe drug products, a power it currently does not have. Source: Drug GMP…
J&J to Start Largest Phase 3 Vaccine Trial Yet in September
Johnson & Johnson (J&J) expects to begin the largest late-stage trial for a COVID-19 vaccine candidate to date early next month if results from its early-stage studies pan out. Source:…
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…
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
LumiraDx Rapid COVID-19 Test Authorized for Emergency Use
The company said it plans to produce 2 million tests in September, increasing to 10 million tests in December. Source: Devices & Diagnostics Letter
OpGen Earns CE Mark for COVID-19 Diagnostic
The diagnostic runs on real-time PCR detection systems, including Applied Biosystems’ QuantStudio 5 and Bio-Rad’s CFX96. Source: Devices & Diagnostics Letter
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