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1. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy

nlm:nlmuid-101704830-pdf

2. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications

nlm:nlmuid-101704838-pdf

3. Health document submission requirements for tobacco products: (revised)

nlm:nlmuid-101733958-pdf

4. Registration and product listing for owners and operators of domestic tobacco product establishments: (revised)

nlm:nlmuid-101733965-pdf

7. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101734447-pdf

8. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101719809-pdf