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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry  Food and Drug Administration (FDA) Proposed
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation  Food and Drug Administration (FDA) Proposed
Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome Instrument for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use   Food and Drug Administration (FDA) Proposed
Exculpatory Language in Informed Consent  Food and Drug Administration (FDA) Proposed
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry  Food and Drug Administration (FDA) Proposed
Fabry Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
FDA’s guidance on uniform national policy (Section 585 of the FD&C Act)  Food and Drug Administration (FDA) Proposed
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
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