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The FDA issued an update yesterday on its inspection performance for fiscal 2021, indicating that it had surpassed its projections for completed inspections by more than 30 percent due to new approaches introduced during the pandemic. Read More
Dercher Enterprises of Upper Darby, Pa., doing business as Gordon Laboratories, was hit with an eight-observation Form 483, and the company’s new quality director told FDAnews that he’s working to pull the company into full compliance. Read More
Public Citizen has called on the FDA to take strong action against two Minneapolis, Minn., investigators and the institutional review board (IRB) at Hennepin County Medical Center (HCMC) over investigational new drug (IND) and informed consent issues on some of their trials. Read More
The two-dose Pfizer-BioNTech COVID-19 vaccine regimen was 100 percent effective in preventing disease in children aged 12-15 years, the companies reported. Read More
Arcus is now “well-positioned to accelerate and expand clinical development activities … [for] patients with some of the most difficult to treat cancers, including pancreatic, lung, colon and prostate,” said Arcus CEO Terry Rosen. Read More