Lauren
R.
Silvis
Associate
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LAUREN R. SILVIS is an associate in the Food and Drug Practice, focusing on FDA regulation of pharmaceuticals, biological products, and medical devices.
Ms. Silvis advises clients on drug and device safety issues, the regulation of clinical trials, recalls and FDA inspections, good manufacturing practice and the quality system regulation, the promotion of FDA-regulated products, import and export issues, and the regulation of over-the-counter drugs. She has worked on major transactions involving FDA-regulated firms and has conducted regulatory due diligence for both buyers and sellers of public and private companies. Ms. Silvis has also worked with clients in the food, dietary supplement, and cosmetic industries.
Recently, Ms. Silvis has:
- Counseled drug and device manufacturers on compliance with clinical trial requirements, including clinical trial disclosure and results posting, patient registries, safety reporting, and negotiating clinical trial agreements;
- Assisted clients in responding to inquiries and investigations into marketing practices;
- Provided regulatory advice to manufacturers of in vitro diagnostic devices regarding pathways to market for new products and the regulation of laboratory-developed tests.
Ms. Silvis served as a law clerk to the Honorable James L. Ryan on the United States Court of Appeals for the Sixth Circuit. She received her J.D., cum laude, from Georgetown University Law Center in 2002, where she was a notes editor for The Georgetown Law Journal. She received her A.B., cum laude, from Duke University in 1998.