CDER Guideline and Guidances for Submissions

Guidelines That Are Applicable to the Center for Drug Evaluation and Research's Regulations - FDA Drug Information Branch. Additional guidances, guidelines, letters to industry, etc., are available through CDER's FAX-on-Demand (FOD) Service at 800-342-2722 or 301-827-0577.

To receive a daily e-mail notification of new material on CDER's website, send a subscription message to fdalists@sabrina.fda.gov.In the message body enter: subscribe cdernew youremailaddress@yourdomain.

A review article in Pharmaceutical Technology, October 1996 provides an overview of FDA guideline/guidance initiatives.

A presentation by FDA Reviewer, Dr. David Katague, summarizes the format and content of submissions.

• Binders for Submissions

• Guidance Documents - General Reference Page

• Guideline for Drug Master Files

  Additonal DMF references can be found at the following sites:
  [Packaging Guideline] [Drug Product Guideline] [Drug Substance]
  [Sterilization Information] [FDA Presentation]

• GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG PRODUCTS
  
• Guideline for the Determination of Dissolution of Solid Oral Dosage Forms

• GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG SUBSTANCES 

• Guideline For Industry - Impurities in Drug Substances - ICH 3A (published in January 4, 1996 F.R.)
  
• Guideline for Industry - Impurities in Drug Products - ICH 3B (published in May 19, 1997 F.R.)
  
• Guideline for Industry - Validation of Analytical Procedures: Methodology - ICH 2B (published in May 19, 1997 F.R.)
  
• Draft Guideline on Impurities: Residual Solvents; Availability (published in May 2, 1997 F.R.)
  
• General list of CDER Documents from the FDA's "gopher" site - considered to be "legacy", i.e., information in an older internet format. The Industry Guidance section of this list can be obtained directly by going to the site immediately below.
  
• Industry Guidance Directory - This site contains documents in various word-processing formats. WP 52 and WP6 are WordPerfect 5.2 and 6.0, respectively. Files in PDF format are based on an the Adobe Corporation portable document format, hence PDF.
  
• CMC Section of an Annual Report
  
• Content and Format of INDs for Phase 1 Studies of Drugs (Acrobat)
  
• Content and Format of INDs for Phase 2 and 3 Studies of Drugs (Acrobat)
   
• Reviewer Guidance - Validation of Chromatographic Methods
  
• Text on Validation of Analytical Procedures (Definitions of Terms)
  
• Photostability Testing of New Substances and Products
  
• Stability Testing for New Dosage Forms
  
• Sterilization Process Validation
  
• GUIDELINE FOR SUBMITTING DOCUMENTATION FOR PACKAGING FOR HUMAN DRUGS AND BIOLOGIC
  
  • Draft Packaging Guidance - June 1997
    

• GUIDELINE FOR SUBMITTING SAMPLES AND ANALYTICAL DATA FOR METHODS VALIDATION
  
• Guidance for Industry Immediate Release Solid Oral Dosage Forms (SUPAC-IR) - Double click on this link to get to SUPAC IR: The first click takes you to Biopharmaceutics/Pharmacokinetics.
  

• SUPAC-IR Draft Addendum for Manufacturing Equipment Changes - 2/3/97 (Acrobat)

• Letter to Industry from Roger Williams - 2/18/97

• SUPAC-SS: Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (Issued 5/97; Posted at FDA 6/16/97)
  
• FDA'S POLICY STATEMENT FOR THE DEVELOPMENT OF NEW STEREOISOMERIC DRUGS - Publication Date: 5/1/92
  
• FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products

• Guidance Oral (extended) Release Dosage Forms In Vivo Bioequivalence and In Vitro Dissolution Testing

• Guideline on Structure and Content of Clinical Study Reports (ICH Guideline published in July 17, 1996 F.R.) or here in "guideline format"

• Single Dose Acute Toxicity Testing for Pharmaceuticals; Revised Guidance; Availability; Notice

• The Extent of Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life Threatening Diseases

• Clinical Safety Data Management: Definitions and Standards for Expediting Reporting

• Dose Response Information to Support Drug Registration

• Studies in Special Populations: Geriatrics (ICH-E7)

Note: See the EMEA reference page at this site for more information about ICH guidelines.

to Home Page Table of Contents