DRUGS: DESCRIPTION

McKenna Long & Aldridge lawyers advise manufacturers, distributors and retailers of prescription and over-the-counter (OTC) pharmaceuticals on issues such as:

• Strategy, content and preparation of investigational new drug (IND) applications
• Issues relating to the new drug approval (NDA) process, including the preparation and processing of full and abbreviated new drug applications (ANDA) and the development of "orphan" drugs
• Petitions and other materials for submission to FDA, including the OTC Drug Review
• Agency initiatives in drug regulation
• DEA enforcement proceedings and related regulatory matters

We also work with contract research organizations (CROs) on regulatory and contractual matters.