The Health Products and Food Branch (HPFB) of Health Canada is pleased to announce the launch of Phase II of the Summary Basis of Decision (SBD) project. This project is part of HPFB's ongoing commitments to enhance the transparency of the pharmaceutical, biologic and medical device regulatory review processes, and to provide access to information about Health Canada's decisions to authorize these products for sale in Canada. Read more here.
The Reader's Guide to the Phase II Summary Basis of Decision (SBD) - Drugs and the Reader's Guide to the Phase II Summary Basis of Decision (SBD) - Medical Devices describe the new Phase II question and answer format of the SBD documents including a summary of information found in the response to each question.
No comments:
Post a Comment