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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention  Food and Drug Administration (FDA) Proposed
Innovative Approaches for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products   Food and Drug Administration (FDA) Proposed
Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Providing Submissions in Electronic Format — Postmarketing Safety Reports  Food and Drug Administration (FDA) Proposed
Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act  Food and Drug Administration (FDA) Proposed
Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999  Food and Drug Administration (FDA) Proposed
Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments  Food and Drug Administration (FDA) Proposed
Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti- Kickback Statute and Beneficiary Inducements CMP  Office of Inspector General (OIG) Proposed
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