New Drug Submissions and Regulatory Processes

Flashcards based on key concepts from the lecture notes on drug submissions and regulatory processes in Canada.

Clinical Trial Application (CTA) is used to __.

Apply for permission to start clinical trials.

The term NDS stands for __.

New Drug Submission.

A Supplemental New Drug Submission (SNDS) is for __.

Making substantial changes to a drug that already has a Notice of Compliance.

The abbreviation ANDS refers to __.

Abbreviated New Drug Submission.

A Notice of Compliance (NOC) indicates __.

That a new drug is approved for sale in Canada.

The process of pharmacovigilance involves __.

Monitoring the safety of a drug after it is on the market.

In Canada, the typical review time for a Priority Review is __ days.

180 days.

Drug submissions must demonstrate that the drug's benefits outweigh its __.

Risks.

The purpose of a New Drug Submission (NDS) is to obtain a __ for a new drug.

License.

Module 3 of the Common Technical Document (CTD) focuses on __.

Quality.