Guidance Agenda:
New & Revised Draft Guidances CDER is
Planning to Publish During
Calendar Year 2013
(See the Good Guidance Practices (GGPs) regulation on this Web page or
21 CFR 10.115 for details about the Guidance Agenda.)
CATEGORY —Advertising
• Considerations for Regulatory Submissions of Promotional Labeling and Advertising Materials
including Submissions in Electronic Format
CATEGORY — Animal Rule
• Product Development Under the Animal Rule
CATEGORY — Biopharmaceutics
• Food-Effect Bioavailability and Fed Bioequivalence Studies---Bioavailability and Bioequivalence
Studies for Orally Administered Drug Products Submitted in New Drug Applications General
Consideration
CATEGORY — Biosimilarity
• Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein
Products
CATEGORY —Chemistry
• Allowable Excess Volume and Labeled Vial Fill Size
• Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in
Abbreviated New Drug Applications
• CMC Postapproval Manufacturing Changes Reportable in Annual Reports for Specified Biological
Products
• Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
• Elemental Impuritiesin Drug Products Marketed in the United States
• Immunogenicity Considerations for Low Molecular Weight Heparin
• Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling
Documentation Version: 07.26.13. Guidances with (*) indicates an addition since previous posting.
CATEGORY —Clinical/Antimicrobial
• Antibacterial Therapies for Patients with Limited or No Alternative Therapies for the Treatment of
Serious Bacterial Disease
• Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment
• Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment
• Pulmonary Tuberculosis: Developing Drugs for Treatment
CATEGORY —Clinical/Medical
• Alzheimer’s Disease: Developing Drugs for the Treatment of Early State Disease
• Common Issues in Drug Development for Rare Diseases
• Developing Drug and Biological Products for Analgesic Indications
• Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)
• Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
• Standards for Clinical Trial Imaging Endpoints
CATEGORY – CMC and CLINICAL/MEDICAL
• Immunogenicity Assessment for Therapeutic Protein Products
CATEGORY —Clinical Pharmacology
• Bioanalytical Methods Validation
New & Revised Draft Guidances CDER is
Planning to Publish During
Calendar Year 2013
(See the Good Guidance Practices (GGPs) regulation on this Web page or
21 CFR 10.115 for details about the Guidance Agenda.)
CATEGORY —Advertising
• Considerations for Regulatory Submissions of Promotional Labeling and Advertising Materials
including Submissions in Electronic Format
CATEGORY — Animal Rule
• Product Development Under the Animal Rule
CATEGORY — Biopharmaceutics
• Food-Effect Bioavailability and Fed Bioequivalence Studies---Bioavailability and Bioequivalence
Studies for Orally Administered Drug Products Submitted in New Drug Applications General
Consideration
CATEGORY — Biosimilarity
• Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein
Products
CATEGORY —Chemistry
• Allowable Excess Volume and Labeled Vial Fill Size
• Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in
Abbreviated New Drug Applications
• CMC Postapproval Manufacturing Changes Reportable in Annual Reports for Specified Biological
Products
• Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
• Elemental Impuritiesin Drug Products Marketed in the United States
• Immunogenicity Considerations for Low Molecular Weight Heparin
• Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling
Documentation Version: 07.26.13. Guidances with (*) indicates an addition since previous posting.
CATEGORY —Clinical/Antimicrobial
• Antibacterial Therapies for Patients with Limited or No Alternative Therapies for the Treatment of
Serious Bacterial Disease
• Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment
• Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment
• Pulmonary Tuberculosis: Developing Drugs for Treatment
CATEGORY —Clinical/Medical
• Alzheimer’s Disease: Developing Drugs for the Treatment of Early State Disease
• Common Issues in Drug Development for Rare Diseases
• Developing Drug and Biological Products for Analgesic Indications
• Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS)
• Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
• Standards for Clinical Trial Imaging Endpoints
CATEGORY – CMC and CLINICAL/MEDICAL
• Immunogenicity Assessment for Therapeutic Protein Products
CATEGORY —Clinical Pharmacology
• Bioanalytical Methods Validation