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In a new guidance on unit-dose repackaged solid oral drugs, the FDA said it will generally not take action on nonconformance with requirements for expiration dating if certain requirements are met. Read More
The FDA handed Georgia-based contract manufacturer Pharma Tech Industries a Form 483 for good manufacturing practice violations at its Royston facility, including the release of drug products before obtaining test results and insufficient complaint investigations. Read More
The FDA has issued a revised draft guidance on complying with labeling requirements for the pregnancy and lactation subsections of prescription drug and biological product labeling. Read More
Maryland-based Emergent BioSolutions was the government’s highest-paid drug or vaccine vendor as of mid-June at $643 million, out of nearly $9 billion issued by HHS for COVID-19, according to a new report released yesterday by the Government Accountability Office (GAO). Read More
Sanofi and GlaxoSmithKline have reached a deal with the British government that will secure up to 60 million doses of the drugmakers’ experimental COVID-19 vaccine for the UK. Read More
Roche’s rheumatoid arthritis blockbuster Actemra (tocilizumab) showed no benefit for hospitalized COVID-19 patients in a phase 3 trial, but the company still has high hopes for the drug as a potential treatment for COVID-19 infections. Read More