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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017   Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessment of Pressor Effects of Drugs Guidance for Industry  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
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Best Practices in Developing Proprietary Names for Drugs  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
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations  Food and Drug Administration (FDA) Proposed
Bioavailability Studies Submitted in NDAs or INDs – General Considerations  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 50245 documents.

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