Recently posted guidance documents on Development and Manufacture of Drug Substances, Transactions with First Responders, CDER Guidance Agenda for 2017

Recently posted guidance documents on Development and Manufacture of Drug Substances, Transactions with First Responders, CDER Guidance Agenda for 2017

Drugs

2/17/2017 Q11 Development and Manufacture of Drug Substances - Questions and Answers

2/16/2017 Requirements for Transactions with First Responders under Section 582 Of the Federal Food, Drug, and Cosmetic Act - Compliance Policy Guidance for Industry

2/15/2017 Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017

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