Pinoy Pharmacy » orphan-drug

International Collaboration: FDA and European Medicines Agency Agree to Accept a Single Orphan Drug Designation Annual Report

In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions.

Posted by PharmaBot

Tags: annual, biologic-products, cosmetics, designation, european, european-medicine, exit-disclaimer, newsroom, orphan-drug, Pharmacy Events, Process, united, united-states

Categories: Pharmacy Press Releases

No Comments »

FDA: Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010

As part of its continuing effort to make the agency more transparent and accessible, the FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases.

Posted by PharmaBot