A Project Manager is working on a project within the pharmaceutical industry. The manager is responsible for ensuring that the project adheres to various compliance requirements. Which of the following would BEST fit into the category of regulatory compliance?
Implementation of a new encryption protocol for data protection
Adhering to internal requirements for marketing and press release approvals
Filing a patent for a newly designed medical device
FDA approval for a new drug is the correct choice because it is a clear example of complying with external, government-mandated regulations that ensure the safety, efficacy, and quality of pharmaceuticals before they reach the market. In contrast, filing a patent for a medical device pertains to intellectual property protection, adhering to internal marketing and press release approvals relates to company-specific guidelines, and implementing a new encryption protocol is an IT security measure rather than a regulatory requirement.
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Why is FDA approval considered regulatory compliance?
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