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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Draft Guidance for Industry   Food and Drug Administration (FDA) Proposed
Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls: Draft Guidance for Industry and FDA Staff   Food and Drug Administration (FDA) Proposed
Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Surveying, Leveling, or Alignment Laser Products: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards   Food and Drug Administration (FDA) Proposed
2020 Secretarial Determination to Lower Head Start Center-based Service Duration Requirement  Administration for Children and Families (ACF) Proposed
Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (Spanish Translation)  Food and Drug Administration (FDA) Proposed
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations 2001  Food and Drug Administration (FDA) Proposed
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