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The FDA has developed two new documents that it wants drug sponsors to use for annual postmarket reporting and is requesting comments on them in a new draft guidance. Read More
A Phoenix, Arizona hypothyroid drug manufacturer drew an FDA warning letter after investigators discovered a lack of process validation data and stability studies for two drug products that were found to be sub-potent. Read More
California Governor Gavin Newsom has named an 11-person scientific review panel to verify the safety of any FDA-approved COVID-19 vaccine before it is distributed in the state. Read More
Brazil’s President Jair Bolsonaro announced Wednesday that his government will not purchase a COVID-19 vaccine developed by Beijing-based Sinovac, just one day after the country’s health minister announced it would be placing an order. Read More
More than two dozen researchers and experts have penned a letter to HHS Secretary Alex Azar, National Institutes of Health (NIH) officials and pharma company executives, imploring them to shed more light on the clinical trial designs for federally funded COVID-19 vaccine studies. Read More
The Department of Justice (DOJ) announced an $8.3 billion settlement deal with Purdue Pharma Wednesday to resolve criminal and civil probes into the OxyContin manufacturer, which some critics view as insufficient punishment for the company and its owners, the Sackler family. Read More
Brazil’s health regulator ANVISA (Agência Nacional de Vigilância Sanitária) disclosed Wednesday that a participant had died in AstraZeneca’s Brazilian late-stage COVID-19 vaccine trial, though the UK drugmaker said the incident was not grounds for stopping the study. Read More