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USFDA Guidance: Reporting Amount of Listed Drugs and Biological Product and Key Information and Facilitating Understanding in Informed Consent Guidance

FDA intends to establish Technical Conformance Guides (guides) to assist registrants of drug establishments (or their agents) in reporting on the amount of drugs manufactured, prepared, propagated, compounded, or processed for commercial sale.

The guide describes

  1. how first-time users can access FDA’s NextGen Portal6 (the portal) to submit these reports,

  2. the different methods for submitting the reports through the portal, and

  3. the data elements to be included in the reports

All registrants or their authorized agents should use the portal to submit reports on the amount of each listed drug that was manufactured for commercial distribution.

The applicant can submit reports through the portal by

  1. manually entering information, or

  2. uploading data from a comma-separated values (CSV) file.

To know more about how to Report the Amount of Drug Products click this LINK.

This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects by the US Department of Health and Human Services (HHS) as well as the FDA’s proposed rule on the protection of human subjects and institutional review boards.

The guidance covers the provisions of the revised Common Rule, which mandates that informed consent should start with crucial information about the research and that information should be presented in a manner that promotes understanding. Identical provisions are also found in the FDA's proposed rule.

To know more about the Flexible Approaches to Providing Key Information and Identifying Key Information About Basic and Additional Elements of Informed Consent, click this LINK.


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