6/17/2026 8:39:00 PM FDA Issues Draft Guidance Clarifying Use of Form FDA 3542 By Dana Severance Alexander Wharton The FDA has issued new draft Q&A guidance (available here) on Forms FDA 3542a and FDA 3542, providing additional clarity on Orange Book...
6/10/2026 4:17:00 PM What the Supreme Court’s Latest Decision on Skinny Labeling Means for Branded Drug Manufacturers By Alexander Wharton Dana Severance On June 4, 2026 in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., the U.S. Supreme Court issued a unanimous decision that...
8/15/2023 1:48:00 PM Chew on this...Xylazine Legislation Is Here By Womble Bond Dickinson Xylazine is a non-scheduled, non-opioid sedative/analgesic medication that is widely used in veterinary medicine. Xylazine was first...
5/11/2021 7:18:00 PM The U.S. Government Says "Open Sesame": How Science Informs the Regulatory Process By Womble Bond Dickinson On April 23, the President signed the Food Allergy Safety, Treatment, Education and Research Act of 2021 into law, which declares sesame...
3/9/2021 2:33:00 PM The Analysis of Cell Free DNA in Urine for Cancer Diagnosis - A Prospective Alternative to Liquid Biopsy? By Womble Bond Dickinson A promising new technology may make the diagnosis of cancer and genetic mutation testing as easy as performing a urinalysis as part of an...
2/11/2021 4:32:00 PM Virginia is for... Cannabis Lovers... in 2024? By Morgan Persinger While adult-use cannabis legalization has been gaining popular support across the country, many state legislatures have been slow to...
2/9/2021 4:04:00 PM Legal Challenge to the FDA's Approval of "Blood" in Plant-Based Meat By Christine Lawson By now, most of us have seen plant-based "meat" in supermarkets and restaurants. For one of those plant-based meat substitutes,...
1/26/2021 9:04:00 PM Getting Closer to a Definitive Biomarker for Parkinson's Disease By Womble Bond Dickinson Parkinson's disease is a devastating, incurable, progressive and degenerative neurological disease that affects movement. There are no...