Release of Draft (Step 2) ICH Guidance Document: S3A Q&A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling
The above referenced draft guidance was released by the ICH Steering Committee for consultation and is being posted on the ICH website for information and comment in accordance with Step 2 of the ICH process.
How to Get Involved
Comments provided to Health Canada should be submitted by September 8, 2016 in order to allow sufficient time for their assessment and subsequent transmission to the ICH. Comments should be directed to:
Health Canada ICH Secretariat
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott Street, Tunney’s Pasture
Ottawa, Ontario
K1A 0K9
E-mail: HPFB_ICH_DGPSA@hc-sc.gc.ca
Telephone: 613-698-9178
Facsimile: 613-941-1812
Interested parties are encouraged to provide comments and suggestions by September 8, 2016.
Reporting to Canadians
Health Canada will make the results of this consultation available on this web site. If you have any questions, contact Health Canada ICH Secretariat.
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