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HHS Guidance Submissions

HHS Guidance

* Metadata including document title and file name are searchable, however, the contents of the guidance documents that are not in HTML format are currently not keyword searchable.

Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
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
Guidance for Industry 180-Day Exclusivity: Questions and Answers Food and Drug Administration (FDA) Proposed
Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices Food and Drug Administration (FDA) Proposed
Multiple Endpoints in Clinical Trials Guidance for Industry Food and Drug Administration (FDA) Proposed
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling Food and Drug Administration (FDA) Proposed
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry Food and Drug Administration (FDA) Proposed
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices Food and Drug Administration (FDA) Proposed
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations Food and Drug Administration (FDA) Proposed
Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies: Draft Guidance for Industry Food and Drug Administration (FDA) Proposed
Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry: Draft Guidance for Industry Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 37163 documents.

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