Pediatric Review Committee
Achieved significant success for IDM Pharmaceutical, Inc. — whose major product is a pediatric oncology drug that treats a rare bone cancer — when legislation was passed that created the Pediatric Review Committee, which the FDA will use going forward on all cases involving pediatric oncology drugs.Food and Drug (FDA): Overview
Established more than seven years ago, Buchanan's Food and Drug Section is one of the first and largest practices dedicated to helping clients with issues related to the U.S. Food and Drug Administration (FDA).
We know your industry, its regulations and its scientific disciplines. Half of the attorneys in the Food and Drug Section previously worked with the FDA and the rest worked for drug companies and research institutes as scientists or legal counsel. Few firms can match the level of industry, science and FDA experience Buchanan offers to its clients.
Our Food and Drug practice provides counsel to businesses regarding:
- Regulatory enforcement advice
- Life cycle extension
- New product opportunities
- Coalition services
- Antitrust and trade regulation
- Health care reimbursement (CMS)
- Legislative strategies
- International development and marketing
Pooling the firm's resources, we combine legislative and regulatory experience with applied scientific knowledge to help our clients achieve their goals. Because key industry groups are most heavily regulated and monitored by the FDA, attorneys in our Food and Drug Section are integrated with the following industry groups:
- Pharmaceuticals
- Biotechnology
- Technology/Device
- Biological products
- Combination products
- Health Care
- Cosmetics
- Food