4/29/2021 7:38:00 PM FDA Issues First-Ever Notice of Noncompliance for Clinical Trial Reporting, Signals End of Non-Enforcement By Mark Vaders On April 28, 2021, the US Food and Drug Administration (FDA) issued the first-ever Notice of Noncompliance to a drug maker that did not...
4/20/2021 2:53:00 PM FDA Suspends Review for Non-COVID-19 In Vitro Diagnostics (IVD) Submissions and Expects Review Delays in Non-IVD Products By Womble Bond Dickinson A year into the current public health emergency, the FDA’s Center for Devices and Radiological Health (CDRH) announced on Thursday, April...
4/15/2021 8:08:00 PM The Perilous Seas of Prop 65: Safe Harbors Should Not Be Controversial By Mark Vaders Should companies be forced to label their products as containing chemicals “known” to cause cancer despite controversial scientific...
4/8/2021 7:28:00 PM Virginia Accelerates Adult-Use Cannabis Legalization By Morgan Persinger We previously highlighted the Virginia Legislature’s move to legalize adult-use cannabis. This week the Virginia Legislature passed a...
4/6/2021 2:08:00 PM Quo Vadis: A Foodie Tale By Christine Lawson Do you know where your last meal came from? Can you trace your vegetables to the field where they were grown? Do you know where the...
4/1/2021 7:51:00 PM FDA Reissues Notice Announcing Increased OTC Monograph Facility Fees By Christine Lawson On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee...