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HHS Guidance Submissions

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Fourth of a series of letters providing informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I  Food and Drug Administration (FDA) Final
Frequently Asked Questions (FAQs) on the Status of Reprocessed Single Use Devices (SUDs) that receive a Not Substantially Equivalent (NSE) Letter  Food and Drug Administration (FDA) Final
General Considerations for Animal Studies for Cardiovascular Devices - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
General Considerations for the Clinical Evaluation of Drugs  Food and Drug Administration (FDA) Final
General Guidelines for OTC Combination Products  Food and Drug Administration (FDA) Final
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry  Food and Drug Administration (FDA) Final
General/Specific Intended Use - Guidance for Industry  Food and Drug Administration (FDA) Final
Good Laboratory Practice Regulations Questions and Answers  Food and Drug Administration (FDA) Final
Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier  Food and Drug Administration (FDA) Final
Gudiance for Industry: Fish and Fishery Products Hazards and Controls  Food and Drug Administration (FDA) Final
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