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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance  Food and Drug Administration (FDA) Proposed
Attachement - Qualification Process for Drug Development Tools: Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive…  Food and Drug Administration (FDA) Proposed
Bioavailability Studies Submitted in NDAs or INDs – General Considerations  Food and Drug Administration (FDA) Proposed
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action  Food and Drug Administration (FDA) Proposed
Assessment of Pressor Effects of Drugs Guidance for Industry  Food and Drug Administration (FDA) Proposed
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
Notice of Proposed Rulemaking (NPRM) on Designation Renewal System Changes  Administration for Children and Families (ACF) Proposed
2020 Secretarial Determination to Lower Head Start Center-based Service Duration Requirement  Administration for Children and Families (ACF) Proposed
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