Date
Issued |
Title |
Pages |
Doc
(.pdf) |
08/2011 |
Draft Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring |
18 |
 |
08/2011 |
Draft Guidance for Industry: Standards for Clinical Trial Imaging Endpoints |
26 |
|
08/2011 |
Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review |
22 |
|
08/2011 |
Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigations for Medical Devices |
56 |
|
08/2011 |
Guidance for Industry: Bar Code Label Requirements - Questions and Answers (This guidance amends the October 2006 guidance document of the same title by incorporating a revised response to question 12 (Q12). This guidance finalizes the draft guidance entitled “Guidance for Industry: Bar Code Label Requirements—Questions and Answers (Question 12 Update)” dated August 2010, and supersedes the guidance entitled “Guidance for Industry: Bar Code Label Requirements—Questions and Answers” dated October 2006.) (Federal Register Notice: August 11, 2011) |
14 |
|
08/2011 |
Guidance for Industry: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions |
15 |
|
08/2011 |
Guidance for Industry and Food and Drug Administration Staff and Foreign Governments - FY 2012 Medical Device User Fee Small Business Qualification and Certification (As of September 30, 2011, this document supersedes “Guidance for Industry, FDA, and Foreign Governments: FY 2011 Medical Device User Fee Small Business Qualification and Certification,” August 3, 2010.) |
34 |
|
08/2011 |
Guidance for Industry: Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments |
4 |
|
07/2011 |
Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices |
12 |
|
07/2011 |
Draft Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device |
26 |
|
07/2011 |
Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications |
29 |
|
07/2011 |
Draft Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma |
10 |
|
06/2011 |
Draft Guidance: Q11 Development and Manufacture of Drug Substances |
33 |
|
06/2011 |
Guidance for Industry: ICH Q4B: Annex 7(R2) Dissolution Test General Chapter |
8 |
|
06/2011 |
Guidance for Industry Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics |
16 |
|
06/2011 |
Guidance for Industry - Donors of Blood and Blood Components: Notification of Donor Deferral - Small Entity Compliance Guide |
7 |
|
04/2011 |
Guidance for Industry: How to Write a Request for Designation (RFD) |
21 |
|
04/2011 |
Guidance for Industry: "Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type) |
16 |
|
04/2011 |
Guidance for Industry Safety Labeling Changes — Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act |
18 |
|
04/2011 |
Guidance for Industry: Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act |
21 |
|
02/2011 |
Draft Guidance: Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) |
11 |
|
02/2011 |
Draft Guidance: Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies |
27 |
|
02/2011 |
Draft Guidance for Industry and FDA Staff: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets |
31 |
|
01/2011 |
Final Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products |
19 |
|
01/2011 |
Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion |
33 |
|
01/2011 |
Guidance for Industry: Process Validation: General Principles and Practices |
22 |
|
12/2010 |
Draft Guidance for Industry: Electronic Source Documentation in Clinical Investigations |
18 |
|
12/2010 |
Guidance for Industry “Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV. |
22 |
|
12/2010 |
Guidance for Industry: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination |
12 |
|
12/2010 |
Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion (This guidance finalizes the draft guidance entitled, “Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products |
16 |
|
11/2010 |
Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel, Assessment of Blood Donor Suitability and Reporting Certain Changes to an Approved Application (This guidance finalizes the draft guidance "Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus |
6 |
|
11/2010 |
Draft Guidance for Industry and FDA Staff: Dear Health Care Provider Letters:Improving Communication of Important Safety Information |
12 |
|
10/2010 |
Guidance for Industry: Cellular Therapy for Cardiac Disease
(This guidance finalizes the draft guidance entitled “Guidance for Industry: Somatic Cell Therapy for Cardiac Disease |
28 |
|
10/2010 |
Draft Guidance for Industry on Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application |
19 |
|
09/2010 |
Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information |
19 |
|
09/2010 |
Safety Reporting Requirements for INDs and BA/BE Studies |
23 |
|
08/2010 |
Guidance for Industry: Bar Code Label Requirements - Questions and Answers (Question 12 Update) |
6 |
|
07/2010 |
Final Guidance for The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application |
39 |
|
07/2010 |
Final Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers (This document supersedes: Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers, issued July 18, 2006). |
29 |
|
06/2010 |
Draft Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions (This document supersedes "Guidance for FDA Staff: Regulating In Vitro Diagnostic Device (IVD) Studies," issued December 17, 1999.) |
53 |
|
06/2010 |
Final Guidance for Industry: Systemic Lupus Erythematosus — Developing Medical Products for Treatment |
18 |
|
06/2010 |
Guidance for Industry: Lupus Nephritis Caused By Systemic Lupus Erythematosus — Developing Medical Products for Treatment |
12 |
|
05/2010 |
Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program |
7 |
|
05/2010 |
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products |
52 |
|
05/2010 |
Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry |
47 |
|
05/2010 |
Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen |
11 |
|
03/2010 |
Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages |
11 |
|
03/2010 |
Guidance for Industry: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format |
13 |
|
03/2010 |
Guidance for Industry: Non-Inferiority Clinical Trials |
66 |
|
03/2010 |
Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indication |
50 |
|
02/2010 |
Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes |
10 |
|
02/2010 |
Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names |
22 |
|
02/05/2010 |
Guidance for Industry and FDA Staff: Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials |
50 |
|
02/2010 |
Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics |
50 |
|
