| Title | Organization | Date |
|---|
| | | |
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 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 - ICH | 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Draft Guidance for Industry: Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) (PDF - 184KB)  | CDER/CBER |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| Molecular Diagnostic Instruments with Combined Functions - Draft Guidance for Industry and Food and Drug Administration Staff | CDRH/CBER | April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 |
| | | |
| Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)(This document supersedes “User Fees and Refunds for Premarket Notification Submissions (510(k)s)” issued August 27, 2009) | CDRH/CBER | April
2013 |
| | | |
| Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility (This guidance finalizes the draft guidance entitled “Guidance for Industry: Blood Establishment Computer System Validation in the User’s Facility” dated October 2007) ( Federal Register Notice: March 26, 2013) | CBER | April
2013 |
| | | |
| Draft Guidance for Industry Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (PDF - 272KB) | CDER/CBER | March
2013 |
| | | |
| Draft Guidance for Industry and Review Staff, Formal Dispute Resolution: Appeals Above the Division Level (PDF - 241KB) (This draft guidance is a revision of the guidance of the same name that issued in February 2000.)( Federal Register Notice: March 13, 2013) | CDER/CBER | March
2013 |
| | | |
| Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical Products to Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex | CDRH/CDER/CBER/CVM | March
2013 |
| | | |
| Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis (This draft guidance replaces the draft guidance entitled, “Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis,” dated June 25, 2003) ( Federal Register Notice: February 26, 2013) | CBER | March
2013 |
| | | |
| Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals - Questions and Answers(R2) (PDF - 311KB) (This guidance is a revision of the ICH guidance of the same title dated February 2012 (M3(R2) Q&As).) | CDER/CBER | February
2013 |
| | | |
| Draft Guidance for Industry and Review Staff: Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling - Good Review Practice (PDF - 115KB) | CDER/CBER | February
2013 |
| | | |
| Guidance for Clinical Investigators, Industry, and FDA Staff Financial Disclosure by Clinical Investigators (PDF - 166KB) | OGCP/CDER/CBER/CDRH | February
2013 |
| | | |
| Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma (PDF - 96KB) (The guidance announced in this notice finalizes the draft guidance of the same title dated July 2011.)( Federal Register Notice: February 26, 2013.) | CBER | February
2013 |
| | | |
| Guidance for Industry: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements (PDF - 527KB)(Federal Register Notice: February 25, 2013) | CDER/CBER | February
2013 |
| | | |
| Draft Guidance for Industry and Food and Drug Administration Staff - Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act | CDRH/CBER | February
2013 |
| | | |
| Draft Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products (PDF - 238KB) | CDER/CBER | February
2013 |
| | | |
| ICH Guidance - S10 Photosafety Evaluation of Pharmaceuticals (PDF - 349KB) | CDER/CBER | February
2013 |
| | | |
| Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling (PDF - 131KB) | CDER/CBER/CDRH | January
2013 |
| | | |
| Guidance for Industry: E3 Structure and Content of Clinical Study Reports Questions and Answers (R1) | CDER/CBER | January
2013 |
| | | |
| Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations (Federal Register Notice: January 24, 2013) | CDRH/CBER | January
2013 |
| | | |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 164KB) | CDER/CBER | January
2013 |
| | | |
| Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval Modifications to a Combination Product Approved Under Certain Marketing Applications (PDF 102KB) (This guidance supplements existing guidance documents developed by the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Office of Combination Products (OCP). ( Federal Register Notice: January 22, 2013) | OCP/OSMP/OC | January
2013 |
| | | |
| Guidance for Industry and Food and Drug Administration Staff: Acceptance and Filing Review for Premarket Approval Applications (PMA) (PDF 370KB) | CDRH/CBER | December 2012 |
| | | |
| Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policyfor 510(k)s (PDF 1.36MB) | CDRH/CBER | December 2012 |
| | | |
| Guidance for Industry and Food and Drug Administration Staff: eCopy Program for Medical Device Submissions (PDF 604KB) | CDRH/CBER | December 2012 |
| | | |
| Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF 163KB) | CBER/CDER | December 2012 |
| | | |
| Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies (PDF 216KB) | CBER/CDER | December 2012 |
| | | |
| Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide (PDF 30KB) | CBER/CDER | December 2012 |
