Recently Issued Guidance Documents

Recently Issued Guidance Documents

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• Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Guidance for Industry
  CBER, May 2019  (This guidance finalizes the draft guidance of the same title dated July 2018.)

• Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
  OCP/CBER/CDER/CDRH, April 2019

• Review and Update of Device Establishment Inspection Processes and Standards; Draft Guidance for Industry
  ORA/CDRH/CBER, March 2019

• Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research; Draft Guidance for Industry and Food and Drug Administration Staff
  CBER, March 2019  (This guidance finalizes the draft guidance of the same title dated December 2017.)

• Rare Diseases: Natural History Studies for Drug Development; Draft Guidance for Industry
  CDER/CBER/OOPD, March 2019

• Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Guidance for Industry
  CDER/CBER, March 2019

• Pediatric HIV Infection: Drug Development for Treatment; Guidance for Industry
  CDER/CBER, March 2019

• Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Guidance for Industry
  CDER/CBER/OCE, March 2019

• Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Guidance for Industry; Draft Guidance for Industry
  OCE/CDER/CBER, March 2019

• Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients Guidance for Industry; Draft Guidance for Industry
  OCE/CDER/CBER, March 2019

• Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies ; Draft Guidance for Industry
  OCE/CDER/CBER, March 2019

• Cancer Clinical Trial Eligibility Criteria: Brain Metastases;  Draft Guidance for Industry
  OCE/CDER/CBER, March 2019

• Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products; Guidance for Industry
  CDER/CBER, March 2019

• Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance for Industry
  CDER/CBER, March 2019

• Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Guidance for Industry
  CBER, February 2019

• Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Guidance for Industry
  CBER/CDER/OCP, February 2019

• Rare Diseases: Common Issues in Drug Development; Guidance for Industry
  CDER/CBER, February 2019

• Providing Regulatory Submissions in Electronic Format -  Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications; Guidance for Industry
  CDER/CBER, January 2019

• REMS Assessment: Planning and Reporting; Draft Guidance for Industry
  CDER/CBER, January 2019

• Survey Methodologies to Assess REMS Goals That Relate to Knowledge; Draft Guidance for Industry
  CDER/CBER, January 2019

• Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway; Guidance for Industry
  CDER/CBER, January 2019