LINDA PISSOTT REIG, is a Shareholder and co-chair of the FDA Group at Buchanan Ingersoll & Rooney in Newark, New Jersey.  Ms. Reig graduated cum laude from Georgetown University Law Center and summa cum laude from Rutgers University (Newark). 

Ms. Reig focuses her practice on the life sciences industry.  She has extensive experience with the laws and industry standards that apply to the marketing and sale of pharmaceuticals, medical devices, biologics, dietary supplements and medical foods.  Ms. Reig formerly defended product liability and consumer fraud lawsuits filed by patients who alleged injury from pharmaceutical and medical device products.  She now advises companies on best practices for Safety Committee set-up, adverse event monitoring, package label updates and related matters.  She also advises on compliance with industry standards for clinical trials, including recruitment of investigators and subjects. 

She conducts company-wide compliance training for life sciences companies and prepares and implements compliance work plans.  She has extensive experience in drafting Standard Operating Procedures and Policies for corporate compliance programs, negotiating and drafting contracts and advising on consulting arrangements with key opinion leaders.  She participates on Review Committees for both commercial and pre-commercial companies and advises on how to lawfully communicate about FDA-regulated products.  Linda guides companies on how to minimize legal risk while achieving business objectives by ensuring compliance with laws, such as the Anti-Kickback, Off Label Promotion and False Claims Act requirements. 

Ms. Reig assists companies with their state and federal "Sunshine Act" obligations, and advises on aggregate spend, marketing disclosures, clinical trial disclosure, adherence to compliance codes, sales representative licensure and “track and trace” requirements. 

Ms. Reig was previously recognized by the New Jersey Law Journal on its List of 40 Lawyers Under 40, which recognizes individuals who are viewed as future leaders of the New Jersey Bar.  Ms. Reig is co-chair of the BioNJ Legal, Compliance & Regulatory Forum Advisory Committee, which she was instrumental in forming in 2008 and in 2012 was the recipient of the BioNJ Member Service Award.