BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 27.07.1998

CDRH Draft Guidance For Industry: Contents of a Product Development Protocol; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``CDRH Guidance for Industry--Contents of a Product Development Protocol; Draft''. This draft guidance is not final nor is it in effect at this time. This document provides guidance on the content of product development protocol (PDP) applications, expected actions and timeframes in the development of a product under a PDP, and how changes during the course of product development under a PDP should be handled.

Source: Federal Register — Food and Drug AdministrationOpen original release →