Biologics Guidances > Recently Issued Guidance Documents

Biologics Guidances > Recently Issued Guidance Documents

Recently Issued Guidance Documents

Title	Organization	Date
Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF - 110KB)	CDER/CBER/CDRH/OGCP/ORA	August 2013
Guidance for Industry on Providing Submissions in Electronic Format--Postmarket Non-Expedited Individual Case Safety Reports; Technical Questions and Answers (PDF - 104KB)	CDER/CBER	July 2013
Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies ( Federal Register Notice: July 18, 2013)	CBER	July 2013
Draft Guidance for Industry: Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans (PDF - 463KB)	CDER/CBER	July 2013
Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products (PDF - 124KB) ( Federal Register Notice: July 2, 2013)	CBER	July 2013
Draft Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologics	CDER/CBER	June 2013
Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System ( Federal Register Notice: June 17, 2013)	CBER	June 2013
Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally  Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System ( Federal Register Notice: June 17, 2013)	CBER	June 2013
Draft Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices	CDRH/CBER	June 2013
ICH - M2: eCTD Specification Questions and Answers and Change Requests Companion	CDER/CBER	June 2013
Draft Guidance for Industry: Changes to an Approved Application:  Biological Products:  Human Blood and Blood Components Intended for Transfusion or for Further Manufacture (  Federal Register Notice: May 31, 2013)	CBER	June 2013
Draft Guidance for Industry: Rheumatoid Arthritis:  Developing Drug Products for Treatment (This draft guidance is revising the final guidance Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA), February 1999).	CDER/CBER/CDRH	May 2013
Draft Guidance for Industry:Expanded Access to Investigational Drugs for Treatment Use — Qs & As (PDF -75KB)	CDER/CBER	May 2013
Draft Guidance for Industry: Charging for Investigational Drugs Under an IND Qs & As (PDF - 75KB)	CDER/CBER	May 2013
Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components (  Federal Register Notice: May 8, 2013)	CBER	May 2013
Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices (PDF - 1.21MB)	CDRH/CBER	April 2013
Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes  ( Federal Register Notice: April 11. 2013)	CDRH/CBER	April 2013
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk -	CDER/CBER	April 2013
Draft Guidance for Industry:  Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) (PDF - 184KB)	CDER/CBER	April 2013
Molecular Diagnostic Instruments with Combined Functions - Draft Guidance for Industry and Food and Drug Administration Staff	CDRH/CBER	April 2013
Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications (This document supersedes “User Fees and Refunds for Premarket Approval Applications” dated November 24, 2003.) ( Federal Register Notice: April 2, 2013)	CDRH/CBER	April 2013

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• Withdrawn - Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells
  8/17/2011
• Withdrawn - Guidance for Industry: Electronic Submission of Lot Distribution Reports for Biological Products (PDF - 17KB) Recommendations on how to electronically submit lot distribution reports (LDRs) for biological products to the Center for Biological Evaluation and Research (CBER) in a format FDA can process, review, and archive.