NEW & REVISED DRAFT GUIDANCE CDER FDA PLANS TO PUBLISH in 2013: COMPOUNDING IS ON THE LIST

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 Impurities in 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
•
Size and Physical Attributes of Generic Tablets
Version: 01.31.13
CATEGORY — Clinical/Antimicrobial
•
Antibacterial Therapies for Patients with Limited or No Alternative Therapies for the Treatment of Serious Bacterial Diseases
•
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
CATEGORY – CMC and CLINICAL/MEDICAL
•
Immunogenicity Assessment for Therapeutic Protein Products
CATEGORY — Clinical Pharmacology
•
Bioanalytical Methods Validation
•
Clinical Pharmacogenomics: Study Design and Premarketing Evaluation
•
Clinical Pharmacology Consideration for Therapeutics Proteins
•
General Clinical Pharmacology Considerations for Pediatrics Studies for Drugs and Biological Products
CATEGORY — Clinical/Statistical
•
Multiple Endpoints in Clinical Trials
CATEGORY — Current Good Manufacturing Practices (CGMPs)/Compliance
•
Quality Systems Approach to Pharmaceutical cGMP Regulation (OMPQ)
•
Uniformity of In-Process Mixtures (OMPQ)
•
Control of Highly Potent Compounds (OMPQ)
•
Contract Manufacturing Arrangements for Drugs: Quality Agreements
•
Submission of Field Alert Reports and Biological Product Deviation Reports (OMPQ)
•
Pre-Launch Activities Importation Request (PLAIR)
Version: 01.31.13
CATEGORY — Drug Safety Information
•
Best Practices in Developing Proprietary Names to Minimize Medication Errors
•
Providing Postmarket Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)
•
Safety Considerations in Product Design to Minimize Medication Errors.
•
Securing the Drug Supply Chain—Standards for Tracking and Tracing Prescription Drug Packages
•
Safety Considerations for Container Label and Carton Labeling Design to Minimize Medication Errors
CATEGORY — Electronic Submissions
•
Providing Regulatory Submissions in Electronic Format – General Considerations
•
Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
•
Providing Regulatory Submissions in Electronic Format – Postmarketing Safety Reports
•
Providing Regulatory Submissions in Electronic Format – Standardized Study Data
•
Providing Submissions in Electronic Format – Summary Level Clinical Site Data for CDER’s Inspection Planning
•
Providing Submissions in Electronic Format – Postmarket Non-Expedited Individual Case Safety Reports; Technical Questions and Answers
CATEGORY — IND
•
Adverse Events: Collection and Reporting for Secondary Endpoints
CATEGORY — Labeling
•
Drug Names and Dosage Forms
•
Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling
CATEGORY – Pharmacology/Toxicology
•
Endocrine Disruption Potential of Drugs: Non Clinical Evaluation
CATEGORY — Procedural
•
Applying the Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)
•
Expedited Programs for Serious Conditions, Drugs and Biologics
•
Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants
•
Integrated Summary of Safety
•
Investigational New Drug Applications prepared and submitted by Clinical Sponsor Investigators
•
Pediatric Product Development
Version: 01.31.13
Version: 01.31.13
•
Pharmacy Compounding of Human Drugs Under Section 503A of the Federal Food, Drug, and Cosmetic Act
•
Public Disclosure of FDA-Sponsored Studies
•
Prescription Drug Marketing Act (PDMA) Requirements
•
Reporting Drug Sample Distribution Under Section 6004 of the Affordable Care Act
•
Use of a Master File for Shared System Risk Evaluation and Mitigation Strategies
•
Electronic Source Data in Clinical Investigations
Note: Agenda items reflect guidances under development as of the date of this posting.

Source found  here