Our FDA Expertise
Represent and counsel domestic, international pharmaceutical, bulk pharmaceutical (API), medical device and biotech companies, established and startup, brand-name and generic, in all aspects of FDA regulation, advertising and promotion review, agency submissions, corporate practice and compliance, litigation, and allied commercial transactions. Serve on boards of directors of companies in the pharmaceutical and FDA consulting fields
Marketing & Advertising
Serve on promotional review committees (PRC) of pharma and medical device companies; review and approve advertising, marketing campaigns, grants, educational activities. Develop corporate structures for FDA review and compliance; respond to FDA enforcement, correcitve advertising programs
Pharmaceutical
Advise on FDA regulation of pharmaceuticals including brand name, generic, OTC, including requirements for approval (NDA; ANDA), advertising and marketing, product labeling, websites; cGMP compliance; FDA enforcement actions; Application Integrity Policy; pharmacy compounding regulation
Education & Training
Courses to industry on Advertising and Promotion Regulation, train company executives and sales representatives on advertising and marketing compliance; responding to FDA enforcement actions
Medical Devices
Develop, draft, submit 510K applications to FDA. Received approvals for devices including for cardiovascular, dental, electro-stimulation (TENS), wound-healing. Develop strategies for medical device approvals
Commercial
Negotiate and advise on agreements for commercial pharmaceutical and medical device supply, product licensing, joint venture, transfer of drug applications and medical device registrations
Administrative & Litigation
FDA; FTC, DEA, CPSC, OIG representation, state Boards of Pharmacy, formulary committees; product recalls. Federal and state trial practice, arbitration, mediation, appellate litigation; grand jury and Department of Justice investigations
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