Center For Drug Evaluation and Rearch List of Guidance Documents
Guidance documents reprent 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 ud if such approach satisfies the requirements of the applicable statutes, regulations, or both. For information on a specific guidance document, plea contact the originating office (e footnote 1 in recent guidances), or contact the Division of Drug Information in the Office of Training and Communications.
Office of Training and Communications
Division of Drug Information
lend10903 New Hampshire Avenue
Silver Spring, MD 20993
Telephone: 301-796-3400
Fax: 301-847-8714
Internet (I): v/cder/guidance/index.htm
E-mail: druginfo@v
Table of Contents (by Subject Category)
出租车英文
ieeetransactionAdvertising ………………………………………………………………….………..Page 3 Biopharmaceutics ………………………………………………………….………..Page 4 Biosimilarity…………………………………………………………………………...Page 5 Chemistry ………………………………………………………………….…………Page 5 Clinical Antimicrobial ……………………………………………………….…...…..Page 9 Clinical Medical ……………………………………………………………………..Page 12 Clinical Pharmacology ……………………………………………………………..Page 19 CMC - Microbiology ………………………………………………………………..Page 20 Combination Products (Drug/Device/Biologic) ………………………………….Page 20 Current Good Manufacturing Practices/Compliance …………………………...Page 21 Drug Safety ………………………………………………………………………….Page 24 Electronic Submissions ……..……………………………………………………..Page 25 Generic Drug ……………………………
…………………………………………..Page 27 Good Review Practices ………………………………..…………………………..Page 29 ICH …………………………………………………………………………………...Page 29 IND ………………………………………………………………………….………..Page 38 Industry Letters ……………………………………………………………………..Page 38 Labeling ……………………………………………………………………………..Page 39 Modernization Act …………………………………………………………………..Page 41 OTC ……………………………………………………………………………….....Page 42 Pharmacology/Toxicology ……………………………………………..…………..Page 44 Procedural …………………………………………………………………………..Page 45 Small Entity Compliance Guides ………………………………………………….Page 51 Ur Fee …………………………………………………...………………………..Page 51
Advertising Issued
46级成绩
Date
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional
Labeling (I) 1/12/1998
Consumer-Directed Broadcast Advertiments (I) 8/9/1999
Industry-Supported Scientific and Educational Activities (I) 12/3/1997
Product Name Placement, Size, and Prominence in Advertising & Promotional Labeling 1/25/2012
Advertising Draft Issued Date
“Help-Seeking” and Other Dia Awareness Communications by or on Behalf of Drug and
Device Firms (I) 2/10/2004杯子的英文
Accelerated Approval Products -- Submission of Promotional Materials (I) 3/26/1999
Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertiments(I) 2/10/2004
Direct-to-Consumer Television Advertiments -- FDAAA DTC Television Ad Pre-Dismination
Review Program 3/13/2012
2012高考英语
Prenting Risk Information in Prescription Drug and Medical Device Promotion (I) 5/27/2009
Promoting Medical Products in a Changing Healthcare Environment; Medical Product Promotion
by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) (I) 1/5/1998
Biopharmaceutics Issued
Date Bioanalytical Method Validation (I) 5/23/2001
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General
Considerations (Revid) (I) 3/19/2003什么是本初子午线
Corticosteroids, Dermatologic (topical) In Vivo (I) 6/2/1995
文明美德伴我成长Dissolution Testing of Immediate Relea Solid Oral Dosage Forms (I) 8/25/1997
Extended Relea Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In
Vivo Correlations (I) 9/26/1997
Food-Effect Bioavailability and Fed Bioequivalence Studies (I) 1/31/2003
Metaproterenol Sulfate and Albuterol Metered Do Inhalers In Vitro (I) 6/27/1989
Statistical Approaches to Establishing Bioequivalence (I) 2/2/2001
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Imediate Relea Solid Oral
Dosage Forms Bad on a Biopharmaceutics Classification System (I) 8/31/2000
Biopharmaceutics Draft Issued
Date Antifungal (topical) (I) 2/24/1990
Antifungal (vaginal) 2/24/1990
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action
(I) 4/3/2003
Biosimilarity Draft
Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product 2/15/2012
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product 2/15/2012
Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009 2/15/2012
Date Chemistry, Manufacturing, and Controls (CMC) Issued Botanical Drug Products (I) 6/9/2004
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic
Biological Products (I) 7/24/1997
教师节快乐的英语怎么写Changes to an Approved NDA or ANDA (Revid) (I) 4/8/2004
Changes to an Approved NDA or ANDA: Questions and Answers (I) 1/22/2001
Changes to an Approved New Drug Application or Abbreviated New Drug Application;
Specifications -U of Enforcement Discretion for Compendial Changes (I) 11/22/2004
thatisallrightContainer Closure Systems for Packaging Human Drugs and Biologics (I) 7/7/1999
Demonstration of Comparability of Human Biological Products Including Therapeutic
Biotechnology Derived Products (I) 3/26/1996 Development of New Stereoisomeric Drugs (I) 5/1/1992 Drug Master Files (I) 9/1/1989 Drug Master Files for Bulk Antibiotic Drug Sustances (I) 11/29/1999 Environmental Asssment of Human Drug and Biologics Applications (I) 7/27/1998 Filing Protocol - Residual Solvents 11/25/2009 Format and Content for the CMC Section of an Annual Report (I) 9/1/1994 Format and Content of the Microbiology Section of an Application* (I) 2/1/1987 Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for
Anticounterfeiting (I) 10/11/2011 IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls
Information (I) 5/25/2001 INDs for Pha 2 and 3 Studies; Chemistry, Manufacturing, and Controls Information (I) 5/20/2003 Monoclonal Antibodies Ud as Reagents in Drug Manufacturing (I) 3/29/2001 Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products -- Chemistry,
Manufacturing, and Controls Documentation (I) 7/5/2002 NDAs: Impurities in Drug Substances (I) 2/25/2000
