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…
Siemens Healthineers’ MRI Software Cleared
The software can be used with scanners made by Siemens or other manufacturers. Source: Devices & Diagnostics Letter
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:…
Sinopharm to Begin Phase 3 Trial of its COVID-19 Vaccine Candidate in Peru
Sinopharm has announced that it will launch another phase 3 trial of its experimental COVID-19 vaccine candidate, this time in Peru, following a greenlight from the Peruvian health regulator. Source:…
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
EU, CureVac Near Advanced Purchase Agreement for COVID-19 Vaccine
German vaccine maker CureVac and the European Union (EU) are close to finalizing a supply deal for the company’s COVID-19 vaccine candidate that will stock the EU with hundreds of…
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
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