Our lawyers have significant experience in a wide variety of matters involving US Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) regulation of pharmaceuticals, including pioneer and generic drugs, controlled substances and biologics, and over-the-counter drugs. We advise on product development and regulatory compliance. Recent product development-related activities include:

• Preparing orphan drug applications for a new cancer drug and a drug for Lyme disease
• Negotiating with the FDA over and assisting in the implementation of a clinical trial development program for a new drug (New Drug Application (NDA) recently approved)
• Counseling clients on ways to extend patent and exclusivity protection for drug products
• Advising universities on clinical research compliance
• Representing a client in several administrative hearings before a DEA administrative law judge on an application to import two controlled substances

In regulatory counseling, we advise clients on regulatory issues involving marketing and manufacturing of drug and biologic products. Recent regulatory-related activities include:

• Serving as regulatory counsel in support of drug developers’ initial public offerings
• Counseling a client on a nationwide recall of a drug product and limiting adverse publicity
• Conducting a worldwide audit of drug manufacturer’s adverse event reporting compliance
• Developing SOPs for post-marketing compliance issues affecting the promotion of pharmaceuticals
• Advising clients on federal and state pedigree and licensing requirements associated with drug distribution