chapter  19
22 Pages

Ways, Means, and Evolving Trends in the U.S. Registration of Drug Products from Foreign Countries

WithAlberto Grignolo

INTRODUCTION There∗ is continuing interest in the development, U.S. Food and Drug Administration (FDA) approval, and importation of foreign drugs into the U.S. market-still the largest in the world. The existing FDA regulations continue to place significant challenges on both foreign and U.S. manufacturers, and are not expected to become more lenient in the foreseeable future. The drivers of FDA’s position are as follows:

Drug Safety: FDA’s appetite for approving drugs without “sufficient” safety information has been significantly diminished by safety-related withdrawals of approved drugs from the U.S. market; the degree of “data sufficiency” has become more of a moving target, as many companies have discovered in recent years.