Question

When is a complete response letter (CRL) not issued by the FDA in response to a drug marketing application?

-A CRL is not issued if there are inadequate or inaccurate information on the label on how people respond to various dosages of the drug.
-A CRL is not issued if there is a need for additional studies with different populations
-A CRL is not issued if the drug failed to demonstrate effectiveness
-A CRL is not issued if there were safety issues that were observed during the clinical trials
-A CRL is not issued if the drug is approved for marketing

Answer 1

A Complete Response Letter (CRL) is not issued by the FDA if the drug is approved for marketing, while it is used to highlight deficiencies such as failure to demonstrate effectiveness, safety issues during trials, or need for further studies, thus requesting additional information before approval.

Step-by-step explanation:

When the U.S. Food and Drug Administration (FDA) evaluates a New Drug Application (NDA), it can issue a Complete Response Letter (CRL) if it determines that the application cannot be approved in its current form. However, there are certain scenarios wherein a CRL is not issued:

• A CRL is not issued if the drug is approved for marketing. In this case, the drug has met all necessary FDA standards for safety and effectiveness and the pharmaceutical company is allowed to market the drug to the public.
• On the contrary, if a drug fails to demonstrate effectiveness, if there are safety issues observed during clinical trials, if there's a need for additional studies with different populations, or if there's inadequate or inaccurate information on the label regarding how people respond to various dosages, the FDA will issue a CRL to highlight these deficiencies and request additional information or studies.

A CRL is not a final rejection, but a request for additional information or changes that must be addressed before the drug can be approved.