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A federal judge has issued a preliminary injunction blocking Charles River Laboratories (CRL) from harvesting the blood of horseshoe crabs for use in bacterial contamination tests for drugs and vaccines — a move that could lead to a shortage of the much-needed tests. Read More
Manufacturing of Johnson & Johnson (J&J)’s COVID-19 vaccine at Emergent BioSolutions’ Bayview, Md., plant remains on pause as the FDA assesses the company’s response to troubling observations by agency officials at the facility last month. Read More
The agency laid out a lengthy list of harmonized regulatory tools and concepts to improve the management of postapproval changes and to enhance transparency. Read More
For new indications of COVID-19 products, the need for two separate assessment reports will depend on the complexity of the application, the agency said. Read More
A former study coordinator at Unlimited Medical Research, which helped conduct a clinical trial on behalf of GlaxoSmithKline (GSK), has been indicted by the Department of Justice (DOJ) for allegedly falsifying data. Read More
India’s surging COVID-19 cases threaten to derail the global drug supply as the world’s largest producer of generic drugs is unable to secure critical raw materials. Read More
In the latest round of Generic Drug User Fee Act (GDUFA) negotiations, the FDA and industry representatives discussed criteria for issuing Complete Response Letters (CRLs) to facilities that cannot be inspected due to a public health emergency or travel restrictions, among other topics. Read More
The temporary pause was not prompted by drug-related adverse events in either the low- or high-dose adult arms of the phase 1 study, the company said. Read More
The Center for Drug Evaluation and Research’s Office of Surveillance and Epidemiology (OSE) said it aims to prioritize Risk Evaluation and Mitigation Strategy (REMS) assessments and the use of new technologies to evaluate adverse event reports, among other priority activities highlighted in its first-ever annual report released yesterday. Read More
On Capitol Hill in recent days, Republicans have challenged the Biden’s administration’s support of a World Trade Organization (WTO) proposal to temporarily waive patents for COVID-19 vaccines. Read More