Pharmaceutical Advisory Board (PAB) Review
The links below will lead you to specific portions of the Draft Guidance for review. Please note that each section has a link to view or download a PDF of the current draft.
TIP: Please download or open with Acrobat to see previous version comments which will be helpful in your review.
Once you have reviewed the section, please visit the Comments & References page for that section to submit your feedback. Please note that there are line numbers for you to reference for any comments provided.
TIP: You will be able to see all comments once you submit yours. Email addresses must be provided to comment.
Thank you for taking part in this important effort.
*Following are draft Sections as of 11/19/21
Section #1 – Benefit Risk
SUBMIT COMMENTS & REFERENCES FOR BENEFIT RISK DRAFT
Section # 2 – Biomarkers
SUBMIT COMMENTS & REFERENCES FOR BIOMARKERS DRAFT
Section # 3 – Diagnosis
SUBMIT COMMENTS & REFERENCES FOR DIAGNOSIS DRAFT
Section #4 – Natural History
SUBMIT COMMENTS & REFERENCES FOR NATURAL HISTORY
Section # 5 – Cardiac – DMD
SUBMIT COMMENTS & REFERENCES FOR CARDIAC
Section # 6 – Gene Therapy
SUBMIT COMMENTS & REFERENCES FOR GENE THERAPY
