The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?

Which of the following is the PRIMARY purpose of an audit report?

A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?

A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?