Home Forums General Discussion Forum TMF RM 3.3 Reply To: TMF RM 3.3

Karen Williams

The package insert includes details and directions that health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations, and dosage, and how to administer the drug.

IP Instructions: storage and dispensing of IP. Instruction on return of unused IP; Establishing Quality control for IP. The procedures should address adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational product(s) to the sponsor (or alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirement(s))

both are part of the IP process but two separate processes and are filed separately