CAPRA Blog

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Rethinking Cost-Sharing: The Need for Health Insurance Reform in the U.S.

Rethinking Cost-Sharing: The Need for Health Insurance Reform in the U.S.

In the U.S., the system designed to protect Americans from the financial devastation of illness often ends up being the very source of that devastation. While it can be...

Value-Based Drug Pricing in Canada and its Limitations

Value-Based Drug Pricing in Canada and its Limitations

Drug pricing is a complex and controversial issue that often sparks debates among patients, pharmaceutical companies, and the government. Prices can vary significantly...

Addressing Underrepresentation in Clinical Trials: FDA's Diversity Action Plan

Addressing Underrepresentation in Clinical Trials: FDA's Diversity Action Plan

The U.S. Food and Drug Administration (FDA) released a new draft guidance in June 2024 to enhance the diversity of clinical trial participants. The guidance details the...

VIRTUAL HEALTHCARE IN CANADA

VIRTUAL HEALTHCARE IN CANADA

“Virtual care” is defined as any “interaction between patients and/or members of their circle of care, occurring remotely, using any forms of communication or information tech...

Artificial Intelligence – Revolutionizing the Healthcare Industry

Artificial Intelligence – Revolutionizing the Healthcare Industry

What is Artificial Intelligence? Artificial intelligence (AI) is a broad term for a category of algorithms and models that perform tasks and exhibit behaviors such as...

Technology Continues to Transform Healthcare and the Regulatory World

Technology Continues to Transform Healthcare and the Regulatory World

Introduction: Digital health solutions are advancing rapidly in the field of diagnostics, emergency response, hospital management. As the goal of individuals shifts more...

Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada

Rare Diseases and Orphan Drugs Regulatory Framework in Canada: Recent Initiatives by Government of Canada

What are Rare Diseases and How do They Affect Canadians? According to Health Canada, rare diseases are life-threatening, debilitating, or serious and chronic conditions that...

Health Canada changes filing requirements for product monographs

Health Canada changes filing requirements for product monographs

Did you know, effective immediately, Health Canada is changing the submission requirements for second language product monographs for human drugs? This is for only post-life...

Pragmatic Clinical Trials: Testing Treatments in the Real-World

Pragmatic Clinical Trials: Testing Treatments in the Real-World

What is a Pragmatic Clinical Trial? Clinical trials can be designed to be either pragmatic or explanatory. Explanatory trials are designed to find out whether a treatment has...

The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022

The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use – June 28, 2022

The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862)....

3D Printing Our Way To Better Health Care

3D Printing Our Way To Better Health Care

What is 3D Printing? 3-Dimensional (3D) printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is...

Digital Therapeutics - Reshaping the future of medicine

Digital Therapeutics - Reshaping the future of medicine

Digital Therapeutics – Reshaping the future of medicine What is Digital Therapeutics? With healthcare becoming digital, patients today are more empowered than ever before. As...

The Need for Regulatory Innovation in Canada: A Series (Issue 1)

The Need for Regulatory Innovation in Canada: A Series (Issue 1)

The Need for Regulatory Innovation in Canada: A Series (Issue 1) Healthcare innovation has a strong position in Canada. From Insulin to Pacemaker to Polio Vaccine, medical...

Real-World Data/Evidence – increasing use in Healthcare for Regulatory Decision Making

Real-World Data/Evidence – increasing use in Healthcare for Regulatory Decision Making

Real-World Data/Evidence – Increasing use in Healthcare for Regulatory Decision Making What is Real-World Evidence/Data? The availability of real world data (RWD) has been i...

Biosimilars and their Approval in Canada

Biosimilars and their Approval in Canada

BIOSIMILARS AND THEIR APPROVAL IN CANADA Biosimilars are regulated as innovative pharmaceuticals in Canada under Food and Drugs Act and Part C of the Food and Drugs...

FDA’s New Annual Distribution Reporting Requirement under Section 510(j)(3) of the FD&C Act for Reporting the Amount of Commercially Distributed Listed Drugs and Biological Products

FDA’s New Annual Distribution Reporting Requirement under Section 510(j)(3) of the FD&C Act for Reporting the Amount of Commercially Distributed Listed Drugs and Biological Products

Due date (February 15, 2022) approaching for Reporting the Amount for calendar year 2020 In October 2021, the Food and Drug Administration (FDA) issued a Draft Guidance for...

To Distribute or Not to Distribute? Health Canada’s Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada

To Distribute or Not to Distribute? Health Canada’s Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada

Further to Health Canada’s amendments to the Food and Drug Regulations (FDR) to make the provisions under the one-year Interim Order respecting drug shortages (safeguarding t...

Health Canada Draft Revised Guidance Documents on Post-NOC Changes - Quality for Consultation

Health Canada Draft Revised Guidance Documents on Post-NOC Changes - Quality for Consultation

On August 6, 2021, Health Canada issued five draft revised Guidance Documents on Post-Notice of Compliance (NOC) Quality Changes for stakeholder consultation. The proposed...

Health Canada-MHRA Guideline: Increasing Transparency When Presenting Safety Information in the DSUR

Health Canada-MHRA Guideline: Increasing Transparency When Presenting Safety Information in the DSUR

On July 6, 2021, Health Canada and the Medicines and Healthcare products Regulatory Agency (MHRA) jointly published a Guideline on how to increase transparency when...

Health Canada’s Proposal for Clinical Trials Regulatory Modernization

Health Canada’s Proposal for Clinical Trials Regulatory Modernization

On May 20, 2021 Health Canada opened a consultation on its proposal to modernize the regulatory framework for clinical trials related to human drugs, medical devices,...

Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19

Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19

In response to the ongoing need for innovative COVID-19 diagnosis, treatment, mitigation, or prevention options, Health Canada announced the approval of Interim Order No. 2...

Amendments to the Food and Drug Regulations to Replace the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD IO)

Amendments to the Food and Drug Regulations to Replace the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD IO)

As the COVID-19 pandemic continues and its unprecedented challenges rapidly evolve, Health Canada’s (HC) agile regulatory measures, called Interim Orders, continue to play a p...

How Health Canada's ‘Draft Guidance on Electronic Media in Prescription Drug Labelling’ May Affect Drug Advertising

How Health Canada's ‘Draft Guidance on Electronic Media in Prescription Drug Labelling’ May Affect Drug Advertising

Health Canada (HC) launched a consultation on the 'DRAFT Guidance for Electronic Media in Prescription Drug Labelling' on March 12, 2021 and will close it to new input on May...

Drug Reimbursement: Aligned Review Process by CADTH

Drug Reimbursement: Aligned Review Process by CADTH

In an effort to make Pharmaceutical Reviews program more cohesive, transparent, and responsive, on September 30, 2020, The Canadian Agency for Drugs and Technologies in...

Non-medical masks or face coverings: Regulatory considerations in the context of COVID-19

Non-medical masks or face coverings: Regulatory considerations in the context of COVID-19

On July 24, 2020, Health Canada published a notice to industry that explains circumstances under which non-medical masks or face coverings would be subject to the regulatory...