FDA

Companies regulated by the FDA face continuous government scrutiny and encounter a range of legal, regulatory and business challenges, whether they are just starting out or have been in operation for decades.

Advised pharmaceutical companies in assessment of and response to safety signals of potentially life threatening conditions.
Represented a compounding pharmacy during a recall of compounded medications following a FDA and State Board of Pharmacy inspection.
Represented a medical device company on product safety positions taken by the Centers for Disease Control and Prevention and healthcare epidemiology societies.
Represented a pharmacy during an FDA inspection of the pharmacy’s compounding area and activities.
Advised pharmaceutical, medical device and cosmetic companies on advertising claims that required the assessment of clinical trials.
Advised private equity funds during the diligence of both FDA manufacturers and licensed pharmacies.
Helped academic medical centers to develop policies and procedures for managing conflicts of interest and apply them in specific research projects.
Represented pharmacies and wholesale distributors in front of 50 state boards of pharmacy.
Defended pharmaceutical companies in nationwide products liability litigation arising from analgesic, cough-cold and colonoscopy preparation products.