 |
Guidance Documents
Guidance documents represent the Agency's current thinking on a particular
subject. They do not create or confer any rights for or on any person and do not
operate to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute, regulations, or
both. For information on a specific guidance document, please contact the
originating office.
Another method of obtaining guidance
documents is through the Division of
Drug Information.
FDA's move to the White Oak Campus means that names, addresses, and phone numbers listed in Agency guidances may no longer be accurate. If you need to speak to someone, contact the office or division that developed a guidance (see footnote 1 in guidances) or contact CDER's Division of
Drug Information.
Newly Added
Guidance Documents Guidance Documents will be
retained in this section of the page for a period of three months. The most
recently added appears first and they are in the order of the date
they were issued.
* Note: Draft guidances are undergoing
finalization. Please contact the relevant division for the most up-to-date
Agency perspective on an issue. For information on how to electronically submit
a comment on a draft guidance, please see
http://www.fda.gov/opacom/backgrounders/voice.html
Guidances Arranged by Subject
Information About Guidances
Newly Added
Guidance Documents:
Guidance Documents will be
retained on this list for a period of three months. After three months you will find them under their specific "subject" on this page. The most
recently added guidances appears first and they are in the order of the date
they were issued.
Title and Format |
Subject |
Type |
Issue Date |
| Integrated Summary of Effectiveness [PDF] or [HTML] |
Procedural |
Draft
note* |
8/27/2008 |
| Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment [PDF] or [HTML] |
Clinical/Antimicrobial |
Draft
note* |
8/21/2008 |
| Residual Solvents in Drug Products Marketed in the United States [PDF] or [HTML] |
Chemistry |
Draft
note* |
8/6/2008 |
| Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes [PDF] or [HTML] |
CMC Microbiology |
Draft
note* |
8/4/2008 |
| Labeling OTC Skin Protectant Drug Products [PDF] or [HTML] |
Over-the-Counter |
Draft
note* |
8/4/2008 |
E2F Development Safety Update Report [PDF] or [HTML] |
International Conference on Harmonisation
-Efficacy |
Draft
note* |
8/4/2008 |
International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions;
- Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter [PDF] or [HTML]
- Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter [PDF] or [HTML]
- Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter [PDF]
- Annex 5:: Disintegration Test General Chapter [PDF] or [HTML]
|
International Conference on Harmonisation
-Quality |
Draft
note* |
8/4/2008 |
| Information Sheet Guidance
for Sponsors, Clinical
Investigators, and IRBs
Frequently Asked Questions -
Statement of Investigator
(Form FDA 1572) [PDF] |
Procedural |
Draft
note* |
7/29/2008 |
| Current Good Manufacturing Practice for Phase 1 Investigational Drugs [PDF] |
Current Good Manufacturing Practices |
Final |
7/14/2008 |
Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing [PDF] or [HTML] |
Electronic
Submissions |
Draft
note* |
7/10/2008 |
Providing Regulatory Submissions in Electronic Format –Postmarketing Individual Case Safety Reports [PDF] or [HTML]
*Technical specifications associated with this guidance will be provided as stand alone documents. They will be updated periodically independent of the guidance. To ensure that you have the most recent versions of the stand alone documents, check the appropriate center's guidance Web page. For CBER, this Web page is http://www.fda.gov/cber/esub/icsr.htm. For CDER, this Web page is http://www.fda.gov/cder/regulatory/ersr/#Postmarketing.
|
Electronic
Submissions |
Draft
note* |
6/11/2008 |
| Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices [PDF] or [HTML] |
Labeling
&
Clinical/Antimicrobial |
Draft
note* |
6/10/2008 |
| Q3A(R) Impurities in New Drug Substances [PDF] or [HTML] |
International Conference on Harmonisation
-Quality |
Final |
6/6/2008 |
| Indexing Structured Product Labeling [PDF] or [HTML] |
Electronic
Submissions |
Final |
6/2/2008 |
| Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices [HTML] |
Procedural |
Draft
note* |
2/2008 |
International Conference on Harmonisation; Guidance on E15 Pharmacogenomics Definitions and Sample Coding [HTML] or [PDF] |
International Conference on Harmonisation - Efficacy |
Final |
4/7/2008 |
Certifications To Accompany Drug, Biological Product, and Device
Applications/Submissions:Compliance with Section 4020) of
The Public Health Service Act,
Added By Title VIII of The Food and Drug Administration
Amendments Act of 2007
[PDF] |
Procedural
&
FDAAA (Food and Drug Administration Amendments Act) |
Draft
note* |
4/2008 |
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies [PDF] or [HTML]
|
Combination Products |
Draft
note* |
3/26/2008 |
S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use [PDF] or [HTML] |
International Conference on Harmonisation
-Safety |
Draft
note* |
3/24/2008 |
| Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims [PDF] or [HTML] |
Labeling |
Draft
note* |
3/12/2008 |
| Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route [PDF] or [HTML] |
Pharm/Tox |
Draft
note* |
3/7/2008 |
| Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention [PDF] or [HTML] |
Clinical/Medical |
Draft
note* |
2/29/2008 |
| Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products [PDF] or [HTML] |
Procedural |
Final |
2/22/2008 |
| Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions [PDF] or [HTML]
- Annex I: Residue on Ignition/Sulphated Ash General Chapter [PDF] or [HTML]
|
International Conference on Harmonisation
-Quality |
Final |
2/20/2008 |
| Safety Testing of Drug Metabolites [PDF] or [HTML] |
Pharm/Tox |
Final |
2/14/2008 |
Back to Top
Advertising
|
Title and Format |
Type |
Issue Date |
| Accelerated
Approval Products: Submission of Promotional Materials
[PDF] |
Draft
note* |
3/26/1999 |
| Aerosol Steroid
Product Safety Information in Prescription Drug Advertising and Promotional
Labeling [PDF] |
Final |
12/1997 |
Brief Summary: Disclosing Risk Information in Consumer-Directed Print
Advertisements [HTML] [PDF]
- Labeling Example [PDF]
- Labeling Example; Consumer-Friendly Version [PDF]
|
Draft
note* |
2/4/2004 |
| Consumer-Directed Broadcast Advertisements [HTML] or [PDF]
Questions and
Answers (Posted 8/6/1999) |
Final |
8/1999 |
Consumer-Directed Broadcast Advertising of Restricted
Devices [HTML]
or [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
1/26/2004 |
Help-Seeking and Other Disease Awareness
Communications by or on Behalf of Drug and Device Firms [HTML]
or [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
1/26/2004 |
| Industry-Supported Scientific and Educational Activities [HTML] or [PDF] |
Final |
12/3/1997 |
|
Product Name
Placement, Size, and Prominence in Advertising and Promotional Labeling [PDF] |
Draft
note* |
1/1999 |
Back to Top
Biopharmaceutics
|
Title and Format |
Type |
Issue Date |
| Bioanalytical Method Validation [HTML] or [PDF] |
Final |
5/2001 |
Bioavailability and Bioequivalence Studies for Nasal
Aerosols and Nasal Sprays for Local Action [PDF]
Federal Register Notice [ TXT ] [ PDF ]
- Statistical Information from the June 1999
Draft Guidance and Statistical Information for In Vitro Bioequivalence Data [PDF]
| Draft
note* |
4/2/2003
4/11/2003 |
| Bioavailability and Bioequivalence Studies for Orally Administered Drug
Products - General Considerations [HTML]
or [PDF] |
Final |
3/2003 |
| Cholestyramine
Powder in Vitro Bioequivalence [PDF] (Intermin Guidance) |
Final |
7/15/93 |
| Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing [HTML]
or [PDF] |
Final |
6/17/2005 |
| Conjugated Estrogens, USP-LC-MS Method for
Both Qualitative Chemical Characterization and Documentation
of Qualitative Pharmaceutical Equivalence. |
Draft
note*
Withdrawn
FR Notice |
8/12/2005 |
| Corticosteroids,
Dermatologic (topical) In Vivo [PDF] (Issued 6/2/1995, Posted 3/6/1998) |
Final |
6/2/1995 |
| Dissolution Testing
of Immediate Release Solid Oral Dosage Forms [PDF] (Issued 8/1997, Posted 8/25/1997) |
Final |
8/1997 |
| Extended Release
Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In
Vivo Correlations [PDF] |
Final |
9/1997 |
| Food-Effect Bioavailability and Fed Bioequivalence Studies
[HTML] or [PDF] |
Final |
12/2002 |
Metaproterenol
Sulfate and Albuterol Metered Dose Inhalers In Vitro
[PDF] |
Final |
6/27/1989 |
| Potassium Chloride
(slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro
Dissolution Testing [PDF] |
Final |
6/6/1994 |
| Statistical Approaches to Establishing Bioequivalence [HTML] or [PDF] |
Final |
2/2001 |
| Waiver of In Vivo
Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral
Dosage Forms Based on a Biopharmaceutics Classification System.
[HTML] or PDF. |
Final |
8/2000 |
Back to Top
[CGMPs] Current Good Manufacturing
Practice (Pharmaceutical CGMPs for the 21st Century) / Compliance
|
Title and Format |
Type |
Issue Date |
Bar Code Label Requirements--Questions and Answers [PDF]
Federal Register Notice [TXT] [PDF] |
Final |
10/5/2006 |
Comparability Protocols - Protein Drug
Products and Biological Products - Chemistry, Manufacturing,
and Controls Information [PDF]
Federal Register Notice [TXT] [PDF]
|
Draft
note* |
9/3/2003 |
| Compressed Medical
Gases |
Final |
2/1989 |
| Computerized
Systems Used in Clinical Trials [HTML] or [PDF] |
Final |
5/10/2007 |
Current Good Manufacturing Practice for
Combination Products [HTML]
or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
9/29/2004 |
| Current Good Manufacturing Practice for Medical Gases [PDF] Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
5/6/2003 |
| Current Good Manufacturing Practice for Phase 1 Investigational Drugs [PDF] |
Final |
7/14/2008 |
| Expiration Dating
and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron [PDF] |
Final |
6/27/1997 |
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide [HTML]
or [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
5/27/2005 |
| Formal Dispute Resolution: Scientific and
Technical Issues Related to Pharmaceutical CGMP [HTML]
or [PDF] |
Final |
1/11/2006 |
| General Principles of
Process Validation |
Final |
5/1987 |
| Good Laboratory
Practice Regulations Questions and Answers [PDF] |
Final |
3/2/1998 |
| Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities -
FDA Public Health Advisory [HTML] or [PDF] |
Final |
4/5/2001 |
Guidance for
IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent
Requirements for Emergency Research (21 CFR 50.24) Draft released for
comment
Federal Register Notice |
Draft
note* |
8/29/2006 |
| Guideline for
Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin
Test for Human and Animal Parenteral Drugs, Biological Products, and Medical
Devices [PDF] |
Final |
Posted 3/2/1998 |
INDs--Approaches to Complying with CGMP's for
Phase 1 Drugs [HTML]
or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
1/12/2006 |
| Investigating Out-of-Specification Test Results for Pharmaceutical Production [PDF] or [HTML] |
Final |
10/11/2006 |
| Manufacturing,
Processing, or Holding Active Pharmaceutical Ingredients[PDF] |
Draft
note* |
4/17/1998 |
| Marketed Unapproved Drugs -- Compliance Policy Guide
[HTML] or [PDF] |
Final |
6/8/2006 |
| Monitoring of
Clinical Investigations [PDF] |
Final |
Posted 3/2/1998 |
| Nuclear Pharmacy
Guideline Criteria for Determining When to Register as a Drug
Establishment [PDF] |
Final |
Posted 3/2/1998 |
| Part 11, Electronic Records; Electronic
Signatures — Scope and Application [HTML]
[PDF] |
Final |
9/3/2003 |
| PAT — A Framework for Innovative
Pharmaceutical Development, Manufacturing, and Quality
Assurance [HTML] [PDF] |
Final |
9/29/2004 |
| PET Drug Products - Current Good Manufacturing Practice (CGMP) [HTML]
or [PDF] |
Draft
note* |
9/15/2005 |
| Pharmacy Compounding -- Compliance Policy Guide
[PDF] |
Final |
5/2002 |
| Possible Dioxin/PCB Contamination of Drug and Biological Products [HTML] or [PDF] |
Final |
8/23/1999 |
Powder Blends and Finished Dosage Units —
Stratified In-Process Dosage Unit Sampling and Assessment [HTML]
[PDF]
Federal Register Notice [TXT] [PDF]
- Revised Attachments [PDF]
|
Draft
note* |
11/2003 |
| Preparation of
Investigational New Drug Products (Human and Animal) [PDF] |
Final |
11/1992 |
Prescription Drug Marketing Act — Donation of Prescription Drug Samples to
Free Clinics [HTML] or [PDF]
- Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers [PDF] (Issued and Posted 11/13/2006)
|
Final |
3/2006 |
Quality Systems Approach to Pharmaceutical
Current Good Manufacturing Practice Regulations [HTML] or
[PDF]
Federal Register Notice [TXT] [PDF] |
Final |
9/27/2006 |
| Questions and Answers on
Current Good Manufacturing Practices (cGMP) for Drugs |
Final |
8/4/2004 |
| Review of FDA's
Implementation of the Drug Export Amendments of 1986 [PDF] |
Final |
11/1989 |
| Sterile Drug Products Produced by Aseptic
Processing — Current Good Manufacturing Practice [HTML]
[PDF] |
Final |
9/29/2004 |
| Street Drug Alternatives [HTML] or [PDF] |
Final |
3/2000 |
| Testing of Glycerin for Diethylene Glycol [ HTML] or [PDF] |
Final |
5/1/2007 |
| The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Good Manufacturing Practice (CGMP) [PDF] or [HTML] |
Draft
note* |
10/18/2007 |
Back to Top
Chemistry
|
Title and Format |
Type |
Issue Date |
Analytical Procedures
and Methods Validation. Optional format:
PDF.
Federal Register Notice [TXT] [PDF] |
Draft
note* |
8/2000 |
| BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives
Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
2/2001 |
Final |
Withdrawn as per FR notice June
1, 2006 |
| Botanical Drug Products [HTML] or
[PDF] |
Final |
6/2004 |
| Changes to an
Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
[PDF] |
Final |
7/1997 |
| Changes to an Approved NDA or ANDA
[HTML] or
[PDF] |
Final |
4/2004 |
| Changes to an Approved NDA or ANDA: Questions and Answers
[HTML] or
[PDF] |
Final |
1/2001 |
| Changes to an Approved NDA or ANDA; Specifications Use of
Enforcement Discretion for Compendial Changes [HTML] or
[PDF] |
Final |
11/19/2004 |
Comparability Protocols -- Chemistry, Manufacturing, and
Controls Information
[PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
2/2003 |
Container Closure Systems for Packaging Human Drugs and Biologics
[HTML] or
[PDF]
- Container Closure Systems for Packaging Human Drugs and Biologics --
Questions and Answers [PDF]
|
Final |
5/1999
5/2002 |
| Demonstration of
Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products |
Final |
4/1996 |
| Development of New
Stereoisomeric Drugs |
Final |
5/1/1992 |
Drug Master Files
Current DMF Information
(e.g. lists, addresses, guidances, etc.) |
Final |
9/1/1989 |
| Drug Master Files for Bulk Antibiotic Drug Substances
[HTML] or [PDF] |
Final |
11/1999 |
| Drug Product: Chemistry,
Manufacturing, and Controls Information 1/2003 |
Draft
note* |
Withdrawn as per FR notice June
1, 2006 |
| Drug Substance: Chemistry,
Manufacturing, and Controls Information 1/2004 |
Draft
note* |
Withdrawn as per FR notice June
1, 2006 |
| Drugs, Biologics, and
Medical Devices Derived from Bioengineered Plants for Use in Humans and
Animals [PDF] |
Draft
note* |
9/11/2003 |
| Environmental
Assessment of Human Drug and Biologics Applications [PDF] |
Final |
7/1998 |
| Format and Content
of the Chemistry, Manufacturing and Controls Section of an Application* 2/1987 |
Final |
Withdrawn as per FR notice June
1, 2006 |
| Format
and Content for the CMC Section of an Annual Report [PDF] |
Final |
9/1/1994 |
| INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and
Controls Information [HTML] or [PDF] |
Final |
5/20/2003 |
| IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and
Controls Information [HTML] or [PDF] |
Final |
5/2001 |
Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug
Regulations [HTML] or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
7/24/1999 |
Liposome Drug Products: Chemistry, Manufacturing,
and Controls; Human Pharmacokinetics and Bioavailability; and Labeling
Documentation. [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
7/2002 |
| Monoclonal Antibodies Used as Reagents in Drug Manufacturing [HTML] or [PDF] |
Final |
3/2001 |
| Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products [HTML] or [PDF] |
Draft
note* |
11/13/1998 |
| Nasal Spray and Inhalation Solution, Suspension, and Drug Products [HTML]
or [PDF] |
Final |
7/2002 |
| NDAs: Impurities in Drug Substances [HTML] or [PDF] |
Final |
2/2000 |
| Orally Disintegrating Tablets [HTML] or [PDF] |
Draft
note* |
4/6/2007 |
| PAC-ATLS:
Postapproval Changes - Analytical Testing Laboratory Sites [PDF] |
Final |
4/28/1998 |
| Residual Solvents in Drug Products Marketed in the United States [PDF] or [HTML] |
Draft
note* |
8/6/2008 |
Reviewer Guidance,
Validation of Chromatographic Methods [PDF]
(revised to include graphics, 5/14/2007) |
Final |
11/1994 |
| The
Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by
Bovine Spongiform Encephalopathy (BSE) |
Final |
12/20/2000 |
| Stability Testing
of Drug Substances and Drug Products 6/5/1998 |
Draft
note* |
Withdrawn as per FR notice June
1, 2006 |
| Submission of
Chemistry, Manufacturing, and Controls Information for Synthetic Peptide
Substances 11/1994 |
Final |
Withdrawn as per FR notice June
1, 2006 |
| Submitting Documentation for the Manufacturing of and Controls for Drug
Products* [HTML]
or [PDF] |
Final |
2/1987 |
| Submitting
Documentation for the Stability of Human Drugs and Biologics* (Issued
, Posted 3/2/1998) |
Final |
Withdrawn as per FR notice June
1, 2006 |
| Submitting Samples
and Analytical Data for Methods Validation |
Final |
2/1987 |
| Submitting
Supporting Documentation in Drug Applications for the Manufacture of Drug
Substances [PDF] |
Final |
2/1987 |
| SUPAC-IR:
Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes:
Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In
Vivo Bioequivalence Documentation [PDF] |
Final |
11/1995 |
| SUPAC-IR Questions
and Answers about SUPAC-IR Guidance |
Final |
2/18/1997 |
| SUPAC-IR/MR:
Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing
Equipment Addendum [PDF] |
Final |
1/1999 |
| SUPAC-MR: Modified
Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry,
Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo
Bioequivalence Documentation [PDF] |
Final |
Issued 10/6/1997 |
| SUPAC-SS:
Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum [PDF] |
Draft
note* |
12/1998 |
| SUPAC-SS:
Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes:
Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo
Bioequivalence Documentation [PDF] |
Final |
5/1997 |
Back to Top
Clinical Antimicrobial
|
Title and Format |
Type |
Issue Date |
| Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment [PDF] or [HTML] |
Draft
note* |
8/21/2008 |
| Acute Bacterial
Meningitis Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Acute Bacterial
Sinusitis Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
10/29/2007 |
| Acute or Chronic
Bacterial Prostatitis Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Acute Bacterial Otitis Media: Developing Drugs for Treatment [PDF] or [HTML] |
Draft
note* |
1/17/2008 |
| Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval [PDF] or [HTML] |
Draft
note* |
10/12/2007 |
Antiviral Product Development--Conducting and
Submitting Virology Studies to the Agency [PDF]
or [HTML]
- Guidance for Submitting HIV Resistance Data [HTML]
or [PDF]
- Guidance for Submitting Influenza Resistance Data [HTML]
or [PDF]
- Guidance for Submitting HBV Resistance Data [HTML]
or [PDF]
- Guidance for Submitting HCV Resistance Data [HTML]
or [PDF]
|
Final |
6/2/2006 |
| Antiretroviral Drugs Using Plasma HIV RNA Measurements Clinical
Considerations for Accelerated and Traditional Approval [HTML]
or [PDF] |
Final |
10/2002 |
|
Bacterial Vaginosis
Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs
for Treatment [HTML] or [PDF]
Federal Register Notice [ TXT ] [ PDF ] |
Draft
note* |
10/1999 |
| Clinical Development and Labeling of Anti-Infective Drug Products [HTML] or [PDF] |
Final |
10/1992 Revised 2/12/2001 |
| Clinical
Evaluation of Anti-Infective Drugs (Systemic) [PDF] |
Final |
9/77 |
| Community-Acquired
Pneumonia Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Complicated Urinary Tract Infections and Pyelonephritis
Developing Antimicrobial Drugs for Treatment [HTML] or [PDF] |
Draft
note* |
7/22/1998 |
| Developing
Antimicrobial Drugs General Considerations for Clinical Trials [PDF] [Main Document] |
Draft
note* |
7/22/1998 |
Developing Antimicrobial Drugs to Treat Inhalational Anthrax (Post Exposure) --
[HTML]
or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
3/15/2002 |
| Empiric Therapy of
Febrile Neutropenia Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Evaluating
Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug
Products [PDF] |
Draft
note* |
2/18/1997 |
| Lyme Disease
Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Nosocomial
Pneumonia Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development
[PDF] or [HTML]
|
Final
|
10/30/2007 |
| Secondary Bacterial
Infections of Acute Bronchitis Developing Antimicrobial Drugs for
Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention [PDF] or [HTML] |
Draft
note* |
11/21/2007 |
| Streptococcal
Pharyngitis and Tonsillitis Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Uncomplicated and
Complicated Skin and Skin Structure Infections Developing Antimicrobial
Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Uncomplicated
Gonorrhea Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998, |
| Uncomplicated
Urinary Tract Infections Developing Antimicrobial Drugs for Treatment [PDF] |
Draft
note* |
7/22/1998 |
| Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices [PDF] or [HTML] |
Draft
note* |
6/11/2008 |
Vaccinia Virus Developing Drugs to Mitigate Complications
from Smallpox Vaccination [HTML] or
[PDF]
Federal Register Notice [TXT] [PDF]
|
Draft
note* |
3/8/2004 |
| Vulvovaginal
Candidiasis Developing Antimicrobial Drugs for Treatment
[PDF] |
Draft
note* |
7/22/1998 |
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Clinical/Medical
|
Title and Format |
Type |
Issue Date |
| Acceptance of Foreign Clinical Studies
[HTML] or
[PDF] |
Final |
3/12/2001 |
Acne Vulgaris: Developing Drugs for Treatment [HTML]
or [PDF]
Federal Register Notice [TXT] [ PDF] |
Draft
note* |
9/16/2005 |
| Allergic Rhinitis: Clinical Development Programs for Drug Products [HTML] or [PDF] |
Draft
note* |
6/2000 |
| Antianxiety Drugs--Clinical
Evaluation [PDF] |
Final |
9/1977 |
| Antidepressant Drugs--Clinical Evaluation [PDF] |
Final |
9/1977 |
| Available Therapy [HTML] or [PDF] |
Final |
7/22/2004 |
| Calcium DTPA and Zinc DTPA Drug Products - Submitting a
New Drug Application [HTML] or [PDF] |
Final |
8/13/2004 |
| Cancer Drug and Biological Products - Clinical Data in Marketing
Applications [HTML]
or [PDF] |
Final |
10/11/2001 |
| Chronic Cutaneous Ulcer and Burn
Wounds -- Developing Products for Treatment [PDF]
or [HTML] |
Final |
6/1/2006 |
| Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment [PDF] or [HTML] |
Draft
note* |
11/8/2007 |
Clinical Development Programs for Drugs, Devices, and Biological Products
Intended for the Treatment of Osteoarthritis [PDF]
Federal Register Notice: [ TXT ] [ PDF ] |
Draft
note* |
7/07/1999 |
| Clinical Development Programs for
Drugs, Devices, and Biological Products for the Treatment of
Rheumatoid Arthritis (RA) [HTML]
or [PDF] |
Final |
1/1999 |
| Clinical Evaluation of Analgesic
Drugs (Withdrawn per August 5, 2003, Federal
Register Notice) |
Final
|
Withdrawn
8/5/2003 |
| Clinical
Evaluation of Antacid Drugs (Withdrawn per July 20, 2004, Federal
Register notice.) |
Final |
Withdrawn
7/20/2004 |
| Clinical
Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and
children) |
Final |
Withdrawn
5/29/2008 |
| Clinical
Evaluation of Antidiarrheal Drugs (Withdrawn per July 20, 2004, Federal
Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
| Clinical
Evaluation of Antiepileptic Drugs (adults and children) [PDF] |
Final |
1/1981 |
| Clinical
Evaluation of Gastric Secretory Depressant (GSD) Drugs (Withdrawn per
July 20, 2004, Federal Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
| Clinical
Evaluation of General Anesthetics [PDF] |
Final |
5/1982 |
| Clinical
Evaluation of Laxative Drugs (Withdrawn per July 20, 2004, Federal
Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
| Clinical Evaluation of Lipid-Altering Agents [PDF] |
Draft
note* |
10/1990 |
| Clinical
Evaluation of Radiopharmaceutical Drugs (Withdrawn per July 20, 2004, Federal
Register notice.) |
Final
Withdrawn |
Withdrawn
7/20/2004 |
Clinical Trial Endpoints for the Approval of Cancer
Drugs and Biologics [HTML] or [PDF]
|
Final |
5/15/2007 |
| Collection of Race and Ethnicity Data in Clinical Trials [HTML]
or [PDF] |
Final |
9/16/2005 |
| Content and Format of
Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs,
Including Well-Characterized, Therapeutic, Biotechnology-derived Products [PDF] |
Final |
11/1995 |
Developing Medical Imaging Drug and Biological Products
- Part 1: Conducting Safety Assessments [HTML]
or [PDF]
- Part 2: Clinical Indications [HTML] or [PDF]
- Part 3: Design, Analysis, and Interpretation of Clinical Studies [HTML]
or [PDF]
|
Final |
6/17/2004 |
| Developing Products for Weight Management Revision 1 [PDF] or [HTML] |
Draft
note* |
2/14/2007 |
| Development and Use of Risk Minimization Action Plans [HTML]
or [PDF] |
Final |
3/24/2005 |
Development of Parathyroid Hormone for the Prevention and Treatment of
Osteoporosis [HTML]
or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
5/2000 |
| Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention [PDF] or [HTML] |
Draft
note* |
2/29/2008 |
Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants
for Use in Humans and Animals [HTML] or
[PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
9/6/2002 |
| Establishing Pregnancy Exposure Registries [HTML]
or [PDF] |
Final |
8/2002 |
| Establishment and Operation of Clinical Trial Data Monitoring
Committees [PDF] |
Final |
3/27/2006 |
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms
and Vulvar and Vaginal Atrophy Symptoms Recommendations for Clinical
Evaluation or [PDF]
Federal Register Notice [TXT] [PDF] |
Draft
note* |
1/2003 |
| Evaluating the Risks of Drug Exposure in Human
Pregnancies [HTML] or [PDF]
|
Final |
4/27/2005 |
| Exercise-Induced Bronchospasm (EIB) Development of Drugs to Prevent
EIB | |
(updated