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...
4/1/2021 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...
3/18/2021 10:13:00 PM Can hashtags get you in trouble? By Womble Bond Dickinson They can if you operate in a regulated industry, such as pharma, med devices, cannabis, dietary supplements, etc.FDA has specific...
10/13/2020 3:27:00 PM Tom’s of Maine Takes Aim at “Duplicate” Class Actions Targeting Its “Natural” Products By Al Windham
9/24/2020 5:24:00 PM Genomic Medicine is Knocking on the Courtroom Door By Christine Lawson Seiko Okada
9/22/2020 5:26:00 PM FDA Approves First of Its Kind Artificial Pancreas for Children 2 to 6 Years Old By Womble Bond Dickinson
9/15/2020 5:29:00 PM Study Estimates Several Hundred Cancer Cases as a Result of First Nuclear Test By Katie Zimmerman
9/8/2020 5:35:00 PM Can a food product with trace pesticide residue be marketed as “natural”? Pending litigation and upcoming FDA guidance may provide an answer. By Al Windham
9/3/2020 5:38:00 PM New blood test to guide personalized cancer treatment By Christine Lawson Seiko Okada