- Assisted with the submission of an Investigational New Drug (IND) application on behalf of the developer of a SARS-CoV-2 vaccine. Alston & Bird’s work included a protocol review, as well as advice regarding the delivery system for the vaccine and assistance addressing FDA questions regarding the application.
- Designed, directed manufacturing procedures, and ensured regulatory compliance of medical devices.
- Developed policies and standards for post-market regulation of laboratory-developed tests (LDTs), the manufacture of medical devices, submission review, inspection, and FDA enforcement.
- Assisted makers and importers of food, raw pet food, baby formula, and tobacco products in conducting recalls.
- Advised clients marketing cannabidiol (CBD) and cannabis products on the legality of those products on a federal level and in label review, marketing, and business risk.
- Audited e-vapor clients for adherence to good manufacturing practices (GMP, also known as tobacco product manufacturing practices (TPMP)) and related regulatory requirements.
- Reviewed food, animal feed, dietary supplement, and tobacco labeling for regulatory compliance, claim substantiation, and litigation risk.
- Developed client opinions on tobacco, food, animal feed, and dietary supplements.
Senior Associate,
- Phone: +1 202 239 3035
- Email: ben.wolf@alston.com
Ben’s training as a biomedical engineer at a cardiac device company and as regulatory counsel at the FDA helps him advise drug, device, food, and tobacco manufacturers.