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The FDA has launched a new online dashboard for adverse event reporting of COVID-19 products that have received Emergency Use Authorizations (EUAs). Read More
Drug manufacturers need to document and report to the FDA if they haven’t been able to comply with postmarket adverse drug experience (PADE) reporting requirements during the COVID-19 pandemic, a former agency compliance official advised. Read More
The Government Accountability Office (GAO) released a new report warning the FDA about the state of its COVID-19-era inspections backlog, cautioning that the agency needs to develop alternative inspections tools. Read More
Johnson & Johnson (J&J) said it is closely monitoring day-to-day operations at its COVID-19 vaccine subcontractor Emergent BioSolutions after a production error at the company’s Baltimore, Md., plant contaminated up to 15 million doses. Read More
The federal government is not missing out on a piece of the action over Gilead Sciences’ antiviral Veklury (remdesivir), which the FDA approved last year to treat hospitalized COVID-19 patients, because the patents rightfully belong to the company, the Government Accountability Office (GAO) reported last week. Read More
The EU expects to see a significant increase in deliveries in the second quarter, allowing it to meet its goal of vaccinating 70 percent or more of its population by July. Read More
HHS has released its latest semiannual regulatory agenda with just four planned drug-related actions by the FDA — three proposed rules and one final rule. Read More
An independent investigation has shown that uniQure’s hemophilia B gene therapy (etranacogene dezaparvovec) was not responsible for a reported case of liver cancer that led to a clinical hold by the FDA on its entire clinical development program for the gene therapy, the company said. Read More
The FDA has not wavered on its October 2020 call for AMAG Pharmaceuticals to withdraw its preterm birth progestin drug Makena and generic versions of it even after a meta-analysis from multiple trials found that it reduced preterm birth before 34 weeks. Read More