1. Guidance Agenda:
New & Revised Draft Guidances CDER is
Planning to Publish During
Calendar Year 2011
(See the Good Guidance Practices (GGPs) regulation on this Web page or
21 CFR 10.115 for details about the Guidance Agenda.)
CATEGORY — Advertising
• Amendment of the Brief Summary: Disclosing Risk Information in Consumer-Directed Print
Advertisements
• Comparative Claims in Prescription Drug and Medical Device Promotion
• Direct to Consumer Television Advertisements - FDAAA DTC Television Pre-Review Program
• Responding to Unsolicited Requests for Prescription Drug and Medical Device Information,
Including Those Encountered on the Internet.
CATEGORY – Biopharmaceutics
• Bioavailability and Bioequivalence Studies for Orally Administered Drug Products Submitted in
New Drug Applications; General Consideration
• Food-Effect Bioavailability Studies for Orally Administered Drug Products
CATEGORY — Chemistry
• Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in
Abbreviated New Drug Applications
• Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information
• Immunogenicity Considerations for Low Molecular Weight Heparin
• Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling
Documentation
• Nongovernment Standards
• Size of Beads in Drug Products Labeled for Sprinkle
• Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
CATEGORY — Clinical/Medical
• Clinical Endpoints for the Approval of Non-Small Cell Lung Cancer
• Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
• Monitoring of Clinical Investigator Conduct and Oversight of Clinical Investigations of Human
Drugs, Devices and Biological Products.
• Standards for Clinical Trial Imaging Endpoints

2. CATEGORY — Clinical Pharmacology
• Bioanalytical Methods Validation
• Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies
• Clinical Pharmacology Consideration for Therapeutics Proteins
• General Clinical Pharmacology Considerations for Pediatrics Studies for Drugs and Biological
Products
• Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling
• Development of Extended Released Formulations
• Use of Histopathology in Biomarker Qualification Studies
CATEGORY — Clinical/Statistical
• Multiple Endpoints
CATEGORY — Combination Products
• Development of Drugs in Combination
CATEGORY — Current Good Manufacturing Practices (CGMPs)/Compliance
• Contract Manufacturing
• Control of Components
• Control of Highly Potent Compounds
• Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide
• Importation of Active Pharmaceutical Ingredients (API) for Use in Human Drugs
• Medical Gases, General CGMP
• Non-Penicillin Beta-Lactam Contamination
• Outsourcer Pharmacy Operations Compliance Policy Guide
• Pharmaceutical Component Quality Control
• Pharmaceutical Manufacturing Statistics
• Pre-Launch Activities Importation Request (PLAIR)
• Prevention and Control of Viral Contamination
• Validation of Air Separation Processes for Medical Gas
• Heparin for Drug and Medical Device Use: Testing for Oversulfated Chondroitin Sulfate
Contamination in Crude Heparin
• Compliance Policy Guide Section 490.200 for FDA Staff: Parametric Release - Drug Products
Terminally Sterilized by Moist Heat
• Pharmacy Compounding of Human Drugs Under Section 503A of the Federal Food, Drug, and
Cosmetic Act
• Good Pharmacy Compounding Practices for Sterile Drug Products
• Compounding Drug Products for the Use in Practitioners Offices

3. CATEGORY — Drug Safety Information
• Best Practices for Conducting and Reporting Phamacoepidemiologic Safety Studies Using
Electronic Healthcare Data
• Naming, Labeling, and Packaging Practices to Reduce Medication Errors
CATEGORY — Electronic Submissions
• Electronic Submission of Summary Level Clinical Site Data for Data Integrity Review and
Inspection Planning in NDA and BLA Submissions
• Providing Regulatory Submissions in Electronic Format – Analysis Datasets and Documentation
CATEGORY — IND
• Adverse Events: Collection and Reporting for Secondary Endpoints
• Good Review Management Principles and Practices for Effective IND Development and Review
CATEGORY – OTC
• Self-Selection Studies for Non Prescription Drug Products
CATEGORY — Labeling
• Drug Names and Dosage Forms
• Indications and Usage Section of Labeling
• Pediatric Information: Incorporating into Human Prescription Drug and Biological Products
Labeling
• Organ-Specific Warnings: Internal Analgesic, Antipyretic and Antirheumatic Drug Products for
Over-the-Counter Human Use-Labeling of Products That Contain Acetaminophen
CATEGORY — Procedural
• Investigational New Drug Applications prepared and submitted by Clinical Sponsor Investigators
• Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act of 2007
(BPCA)
• Pediatric Studies: How to Comply with the Pediatric Research Equity Act, Title IV of the Food and
Drug Administration Amendments Act of 2007
Note: Agenda items reflect guidances under development as of the date of this posting.