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.