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 ConsumerDirected Print Advertisements
Comparative Claims in Prescription Drug and Medical Device Promotion
Direct to Consumer Television Advertisements - FDAAA DTC Television PreReview 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
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
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.