Recently Issued Guidance Documents

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• Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Guidance for Industry
  CBER, November 2022

• Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, November 2022

• Cross Labeling Oncology Drugs in Combination Regimens; Guidance for Industry
  CDER/CBER/OCE, November 2022

• Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry
  CBER, November 2022

• Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Draft Guidance for Industry
  CDER/CBER/OCLiP/OCE, November 2022

• Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide; Guidance for Industry
  CBER, November 2022

• Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry
  CDER/CBER, November 2022

• Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2022

• Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, October 2022

• Human Gene Therapy for Neurodegenerative Diseases; Guidance for Industry
  CBER, October 2022

• Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA; Guidance for Industry
  CDER/CBER, October 2022

• Ethical Considerations for Clinical Investigations of Medical Products Involving Children; Draft Guidance for Industry, Sponsors, and IRBs
  OPT/CDER/CBER/CDRH, September 2022

• Policy for Device Software Functions and Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2022

• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2022

• Clinical Decision Support Software; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER/CDER, September 2022

• Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2022

• Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff
  CDRH/CBER, September 2022

• Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products; Draft Guidance for Industry
  CDER/CBER, September 2022

• Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products; Guidance for Industry
  CDER/CBER/OCE, September 2022

• Charging for Investigational Drugs Under an IND: Questions and Answers; Draft Guidance for Industry
  CDER/CBER/OCLiP/OCE, August 2022