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Found 10 records similar to COVID-19 clinical trials IO and clinical trials records retention: Consultation report

Federal

The purpose of this notice is to advise stakeholders that Health Canada is proposing to: maintain the flexibilities and regulatory oversight provided by the Interim order respecting clinical trials for medical devices and drugs relating to COVID-19 until at least the fall of 2021, and bring forward regulatory amendments that would allow the flexibilities under the Interim Order to continue after the fall of 2021.

Last Updated: Jul. 27, 2021
Date Published: Dec. 10, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, predictability, regulatory oversight, COVID-19 clinical trials, clinical trials, medical devices and drugs, notice to stakeholders, Interim Order
Federal

Sponsors of COVID-19-related drug and vaccine clinical trials can choose between 2 different processes: existing process outlined in the Food and Drug Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: May 1, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, vaccine, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials for drug and vaccine related to COVID-19
Federal

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. Authorization is done through the Medical Device Regulations or the Interim Order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: Jun. 14, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, medical devices, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials related to COVID-19, list of authorized clinical trials
Federal

IO No. 2 supports Canada’s continued focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians.

Last Updated: May 28, 2021
Date Published: Apr. 28, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, Interim Order No. 2, notice, clinical trials, medical devices, drugs, risks, health and safety
Federal

Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, medical devices, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials related to COVID-19
Federal

Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jun. 30, 2021
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, clinical trials, drugs, medical devices, apply for a trial authorization, Medical Devices Regulations, interim order for clinical trials related to COVID-19
Federal

Currently, the treatment of COVID-19 includes supportive care and treatment of any secondary infections, such as pneumonia. There are no drugs or vaccines approved, but there are now 18 clinical trials authorized in Canada with diagnostic equipment, supportive care and/or treatments for COVID-19.

Last Updated: Apr. 23, 2020
Date Published: Apr. 20, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Treatment of COVID-19, drugs, vaccines, clinical trials, diagnostic equipment, supportive care.
Federal

The purpose of this document is to assist in planning immunization clinics for COVID-19 vaccines during the COVID-19 pandemic.

Last Updated: Jan. 25, 2021
Date Published: Dec. 12, 2020
Organization: Public Health Agency of Canada
Formats: HTML
Keywords:  COVID-19, Coronavirus, clinic planning, leadership, coordination, immunization, clinic, human resources, communications
Federal

The Interim Order (IO) No. 2 continues to support the optional pathway introduced by IO No. 1 to facilitate clinical trials for potential COVID-19 drugs and medical devices.

Last Updated: May 28, 2021
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, Interim Order No. 2, Clinical Trials, Medical Devices and Drugs Relating
Federal

The tables below list the COVID-19-related clinical trials which have been authorized by Health Canada through the Food and Drug Regulations or the Interim order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jul. 27, 2021
Date Published: Jun. 14, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, vaccines for COVID-19, drugs for COVID-19, list of authorized clinical trials
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