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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

11. A sense of déjà vu: the debate surrounding state biosimilar substitution laws

nlm:nlmuid-101656652-pdf