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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Redbook 2000: IV.C.9.a.Guidelines for Reproduction Studies  Food and Drug Administration (FDA) Final
Redbook 2000: IV.C.9.b. Guidelines for Developmental Toxicity Studies  Food and Drug Administration (FDA) Final
Redbook 2000: VI.B Epidemiology  Food and Drug Administration (FDA) Final
Redbook 2000: VII Glossary, Acronyms and Definitions  Food and Drug Administration (FDA) Final
Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use  Food and Drug Administration (FDA) Final
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators  Food and Drug Administration (FDA) Final
S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals  Food and Drug Administration (FDA) Final
Seventh of a series of letters about the Act providing guidance on the "130-day exclusivity" provision of section 505(j)(4)(B)(iv) of the FD&C  Food and Drug Administration (FDA) Final
Small Business Nutrition Labeling Exemption Guidance  Food and Drug Administration (FDA) Final
Small Entity Compliance Guide on Structure/Function Claims  Food and Drug Administration (FDA) Final
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