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

3. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

5. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

6. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

8. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

9. Quality attribute considerations for chewable tablets