Concept Papers establish or clarify a concept (or framework); they often describe a potential solution or approach to an existing problem or area of discussion. These papers may interpret or clarify a regulatory position, and may seek to influence. View all Concept Papers.
Discussion Papers promote discussion and creates awareness on new or emerging topics; they often solicit feedback, gauge interest, and seek member or industry input. They may state a problem, provide the tentative exploration of solutions and options, and may suggest potential next steps. View all Discussion Papers.
These handy pocket-size booklets are an ideal way to keep everyone informed of FDA regulations and guidelines. See all GMP Mini Regulation Handbooks.