jueves, 8 de agosto de 2013

Biologics Guidances > Recently Issued Guidance Documents

Biologics Guidances > Recently Issued Guidance Documents


Recently Issued Guidance Documents


TitleOrganizationDate
   
Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF - 110KB) pdf icon smallCDER/CBER/CDRH/OGCP/ORAAugust
2013
   
Guidance for Industry on Providing Submissions in Electronic Format--Postmarket Non-Expedited Individual Case Safety Reports; Technical Questions and Answers (PDF - 104KB)pdf icon small CDER/CBERJuly
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
(disclaimer icon Federal Register Notice: July 18, 2013)
CBERJuly
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Draft Guidance for Industry: Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans (PDF - 463KB)pdf icon smallCDER/CBERJuly
2013
   
Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products (PDF - 124KB)pdf icon small (disclaimer icon Federal Register Notice: July 2, 2013)CBERJuly
2013
   
Draft Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologicspdf icon smallCDER/CBERJune
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Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and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 (disclaimer icon Federal Register Notice: June 17, 2013)CBERJune
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Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally  Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for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 (disclaimer icon Federal Register Notice: June 17, 2013)CBERJune
2013
   
Draft Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Management of Cybersecurity in Medical Devicespdf icon smallCDRH/CBERJune 2013
   
ICH - M2: eCTD Specification Questions and Answers and Change Requests Companionpdf icon smallCDER/CBERJune
2013
   
Draft Guidance for Industry: Changes to an Approved Application:  Biological Products:  Human Blood and Blood Components Intended for Transfusion or for Further Manufacture
(disclaimer icon  Federal Register Notice: May 31, 2013)
CBERJune
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). pdf icon smallCDER/CBER/CDRHMay
2013
   
Draft Guidance for Industry:Expanded Access to Investigational Drugs for Treatment Use — Qs & As (PDF -75KB)pdf icon smallCDER/CBERMay
2013
   
 Draft Guidance for Industry: Charging for Investigational Drugs Under an IND Qs & As (PDF - 75KB)pdf icon small CDER/CBERMay
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
(disclaimer icon  Federal Register Notice: May 8, 2013)
CBERMay
2013
   
Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices (PDF - 1.21MB)pdf icon small CDRH/CBERApril
2013
   
Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes
 (disclaimer icon Federal Register Notice: April 11. 2013)
CDRH/CBERApril
2013
   
M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk CDER/CBERApril
2013
   
Draft Guidance for Industry:  Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) (PDF - 184KB) pdf icon small CDER/CBERApril
2013
   
Molecular Diagnostic Instruments with Combined Functions - Draft Guidance for Industry and Food and Drug Administration Staff CDRH/CBERApril
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.) (disclaimer icon Federal Register Notice: April 2, 2013)CDRH/CBERApril
2013

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