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The FDA has issued a Complete Response Letter (CRL) to San Diego, Calif.-based Acadia Pharmaceuticals for their supplemental New Drug Application for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). Read More
The FDA has identified five main activities it will focus on for improving its COVID-19 Pandemic Recovery and Preparedness Plan (PREPP), including two on its reviews of Emergency Use Authorization (EUA) processes and its approaches to inspections, public communications and supply-chain monitoring. Read More
The FDA is preparing to conduct what it’s calling the first-ever systemic study examining how pharmaceutical brand names influence perceptions about drug efficacy. Read More
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