The Food and Drug Administration (FDA) announces the availability of guidance for industry and investigators on the enforcement of safety reporting requirements for investigational new drug applications and bioavailability/ bioequivalence studies.

FDA issues for comment draft guidance titled “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.”

Fourteen federal district courts in California, Florida, Illinois, Maryland, Nevada, New Jersey, New York, Pennsylvania, Tennessee, and Texas have been selected to participate in a 10-year pilot project designed to enhance expertise in patent cases among U.S. district judges.