Question

CAT I QDRs are reported by routine precedence message within how many working days after the discovery of the deficiency unless combined with an HMR?

Answer 1

CAT I QDRs reporting requirements for adverse drug experiences post NDA approval generally demand reporting within 15 days for serious events and quarterly for others, according to FDA protocols. However, without explicit context for 'CAT I QDRs' or 'combined with an HMR', a definitive time frame for reporting cannot be given.

Step-by-step explanation:

The question pertains to the reporting requirements for CAT I QDRs (Quality Deficiency Reports) in the context of medicinal products. According to the regulatory expectations for drug safety, sponsors must report every adverse drug experience post New Drug Approval (NDA) to the FDA. For unexpected serious and fatal adverse events, the reporting must be within 15 days, while others can be reported on a quarterly basis. This is separate from the spontaneous reports received through the FDA's MedWatch program, which are voluntary in nature. However, in the absence of more specific context such as an acronym definition for 'CAT I QDRs', or the mention of an 'HMR', it is challenging to provide the exact number of working days for reporting as different sectors and contexts might have different reporting protocols.