Blog/group email
🍁 Drugs US VHL Canada
How Are Drugs Reviewed in Canada? Health Canada
- “When a sponsor decides that it would like to market a drug in Canada, it files a ‘New Drug Submission’ with HPFB* … It includes the results of the preclinical and clinical studies, whether done in Canada or elsewhere, details regarding the production of the drug, packaging and labelling details, and information regarding therapeutic claims and side effects…”
*Health Products and Food Branch (HPFB) of Health Canada
Ask your doctor/VHL specialist about clinical trials for drugs or other treatments:
- Is there a clinical trial that would be appropriate for me?
- If I take this treatment, does it make me ineligible for any other treatments/programs?
also
- “Heather, who lives in Calgary, Alberta, shares her experience with accessing [breast cancer] clinical trials in the United States as well as in Toronto" see BLOG
Finding a Clinical Trial (and general info)
How much do clinical trials cost?
- “The average cost of phase 1, 2, and 3 clinical trials across therapeutic areas is around $4, 13, and 20 million respectively… [U.S. Department of Health and Human Services -see table]”
Have you already seen the latest clinical trial update from VHL Alliance on Belzutifan?
- The US FDA (Food and Drug Administration) will make a decision on the approval of Belzutifan by "September 15, 2021". Outside the United States, “Each country and/or group of counties have their own regulatory agencies and corresponding processes to approve a drug…”
Dr. Eric Jonasch, Principal investigator in Phase II clinical trials for Belzutifan; Professor at University of Texas MD Anderson Cancer Center; and on VHLA councils:
- “The hope here is that this agent be approved and that… [patients] could get this drug instead of a surgical intervention and that they could be on this for some period of time...
These are some common questions and themes about "clinical drug trials and when do they I get into Canada", etc. Please share more feedback with us! Thanks, Henry
|