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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VII Biotechnology Final Consultations  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (French Translation)  Food and Drug Administration (FDA) Proposed
Best Practices in Developing Proprietary Names for Drugs  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
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Bispecific Antibody Development Programs Guidance for Industry  Food and Drug Administration (FDA) Proposed
Certification Process of Designated Medical Gases  Food and Drug Administration (FDA) Proposed
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application  Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017   Food and Drug Administration (FDA) Proposed
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