FDA Enquiry Re Sierra28 Jul 2021 19:13
Would you please confirm what action, if any, the FDA is likely to take in respect of the failure by Sierra Oncology Inc to publish the findings of two clinical trials detailed below which concluded in October 2019 and April 2020 respectively.
https://clinicaltrials.gov/ct2/results?cond=&term=sra737&cntry=&state=&city=&dist=
I am very concerned that cancer patients who could benefit from the drug are being denied access to treatment because of ongoing failings by Sierra Oncology.
Thank you for your attention.
Thank you for writing to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research (CDER).
We understand your concerns. FDA cannot comment on drug products in development, in the FDA review process, or that have been denied approval or authorization by FDA, including when and if a drug will be approved or authorized by the FDA, or what FDA’s actions will be. Please understand that this information is confidential according to 21 CFR 314.430, and belongs to the manufacturer/sponsor developing the drug, so we cannot provide it to the public.
Thank you for writing to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research (CDER).
We understand your concerns. FDA cannot comment on drug products in development, in the FDA review process, or that have been denied approval or authorization by FDA, including when and if a drug will be approved or authorized by the FDA, or what FDA’s actions will be. Please understand that this information is confidential according to 21 CFR 314.430, and belongs to the manufacturer/sponsor developing the drug, so we cannot provide it to the public.
Best regards,
RL - Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (888-543-3784)
druginfo@fda.hhs.gov
Best regards,
RL - Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (888-543-3784)
druginfo@fda.hhs.gov
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