BioCentury
ARTICLE | Politics, Policy & Law

Lambreth rules FDA can't hide behind FDAMA

March 8, 1999 8:00 AM UTC

WASHINGTON - U.S. District Court Judge Royce Lambreth has ruled that the FDA's implementation of the Food and Drug Administration Modernization Act (FDAMA) is subject to his landmark 1998 decision that struck down many of the agency's restrictions on dissemination of information about unapproved uses of approved products.

Lambreth, who sits on U.S. District Court for the District of Columbia, ruled that the agency cannot ignore the July 1998 decision simply because the case was initiated prior to FDAMA...