Zdrowie i gospodarka · 01/12/1999

FDA Proposes Changes to Postmarketing Study Reports for Human Drugs and Licensed Biological Products

The FDA is proposing to update its postmarketing reporting requirements for human drugs and licensed biological products, requiring annual status reports for certain postmarketing studies and outlining the types of studies and information to be included in the reports, in order to implement the Food and Drug Administration Modernization Act of 1997.