Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?

In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?