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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials  Food and Drug Administration (FDA) Proposed
Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling  Food and Drug Administration (FDA) Proposed
Q1B Photostability Testing of New Drug Substances and Products  Food and Drug Administration (FDA) Proposed
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry  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of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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