In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?