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With Financial Performance Data you can view financial data based on industry averages.
This guidance document is specific to the "tamper-resistance" feature of controlled-release opioid products. It is intended for the pre-market review of drug submissions when sponsors seek to obtain approval for controlled-release opioid drug formulations with tamper-resistant properties and wish to include, in product monographs, scientific statements and claims regarding tamper-resistance.
Through its Action Plan on Medical Devices, Health Canada is committed to continuing to provide Canadians with more information on the medical devices they use. The Department is pleased to announce that it will begin publishing Regulatory Decision Summaries (RDSs) for all new Class III medical device licences (e.g. orthopedic implants or blood glucose monitors) starting January 31, 2019.
2023 ESDC progress report on how we are meeting the Accessible Canada Act and Regulations
Through the special access program (SAP) for medical devices, health care professionals can access custom-made and unlicensed medical devices for patients under their care.
While hyperbaric oxygen therapy is recognized as an effective treatment for 14 specific conditions listed below, the operators of some private clinics claim it can also be used to treat such conditions as multiple sclerosis, cerebral palsy, cancer, AIDS, stroke and migraine headaches. There is no scientific proof to support these claims.
This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.
Animal-sourced insulins and biosynthetic (man-made) human insulins are used worldwide for managing diabetes. Recently, some concern has been expressed about the overall safety of insulins and the availability of animal-sourced insulins for those patients who cannot manage their disease using biosynthetic human insulin.
An insulin pump is a medical device used by people with diabetes. It's an alternative to multiple daily injections of insulin using a syringe or pen.
This labelling standard applies to ethylene oxide products labelled for use as gaseous sporicides in sterilizing medical instruments/devices. It does not apply to any other liquid and gaseous drug products to be used in sterilizing procedures and equipments for medical instruments/devices.