Appendix M. Canadian and U.S. Pharmaceutical Practices

According to Appendix M, what is the duration of drug patent protection in Canada?

What is the duration of the preclinical testing phase for a new drug as described in Appendix M?

In the United States, what is the process called when a manufacturer seeks permission to begin clinical studies with human subjects, and which body administers it?

How many healthy volunteers are typically recruited for Phase 1 clinical trials according to Appendix M?

What is the primary purpose of a Phase 3 clinical trial?

Which Canadian body regulates the prices that manufacturers can charge for prescription and nonprescription medicines?

What was the key recommendation from the Institute of Medicine (IOM) regarding direct-to-consumer drug advertising in the U.S.?

How are Natural Health Products (NHPs) regulated in Canada?

In the Canadian drug scheduling system defined by NAPRA, what is a Schedule II drug?

Which Canadian province has not adopted the national drug scheduling model defined by the National Pharmacy Regulatory Authorities (NAPRA)?

What is the duration of drug patent protection in the United States according to Appendix M?

In Canada, what is the application process called when seeking permission to begin clinical testing, and which body administers it?

What is the typical number of patient volunteers enrolled in a Phase 2 clinical trial?

What is the term for the ongoing assessment of a drug's safety and effectiveness after it has been marketed?

In the United States, under which act are natural products classified as food products?

What is a key feature of drug advertising regulation in Canada compared to the U.S.?

According to the NAPRA model in Canada, which drug schedule corresponds to products available for open access in a pharmacy only, without a prescription?

What is the primary purpose of a Phase 0 clinical trial?

What is the purpose of the Common Electronic Submissions Gateway (CESG)?

In Canada, what is required for all Natural Health Products (NHPs) before they can be sold?

What is the typical range of patient volunteers for a Phase 3 clinical trial?

In Canada, which schedule includes drugs that can be sold in any store without professional supervision?

What is a major difference highlighted between the U.S. and Canada regarding potentially dangerous drugs like insulin and heparin?

What is the primary purpose of a Phase 2 clinical trial?

According to a study cited in Appendix M, approximately what percentage can U.S. citizens save if they buy their medications from Canadian pharmacies?

After a drug's patent expires, what typically happens in the pharmaceutical market?

Which entities are responsible for approving drug advertising in Canada?

What is a major limitation placed on claims for natural products in the U.S. under the Dietary Supplements Health Education Act?

In the U.S. pharmaceutical system, medications are categorized into which two general classes for accessibility?

What does a Natural Product Number (NPN) issued by Health Canada signify?

What is the primary objective of preclinical testing in the drug development process?

In the Canadian drug scheduling system, a drug that is 'Available only by prescription and provided by a pharmacist' falls under which schedule?

In Canada, who is responsible for deciding the schedule for individual drugs, with the exception of narcotics and controlled substances?

How does the text describe the approval process for new drugs in both the U.S. and Canada?

What is a Homeopathic Medicine Number (DIN-HM) used for in Canada?

What is the defining characteristic of a Phase 3 clinical trial study design?

What happens to the price of a drug after a patent expires and generic versions become available?

What is a significant difference in the regulatory requirements for natural products between Canada and the U.S.?

Which of the following best describes the term 'Over-the-Counter (OTC)' in the U.S. context?

What is the primary focus of a Phase 1 clinical trial?

In the Canadian pharmaceutical system, what does the term 'behind-the-counter' refer to?

What is the main reason cited for the controversy surrounding direct-to-consumer drug advertising in the U.S.?

Which of these is NOT a phase of clinical trials mentioned in Appendix M?

What type of product is included under the term 'Natural Product' in Canada?

What is the key difference between the U.S. and Canada regarding drug pricing controls?

What is a major consequence of the different drug accessibility rules between the U.S. and Canada?

In the Canadian system, a site license is required for what activity related to Natural Health Products?

Why did the Institute of Medicine (IOM) recommend a temporary ban on direct-to-consumer advertising for new drugs?

The process of taking a new drug from the laboratory to the pharmacy shelves includes several steps. Which step occurs first?

What is a key similarity between the US FDA and Health Canada regarding drug approval?