FDA
guideline Agenda for calendar year 2014
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The US Food and Drug Administration (FDA) has released its 2014 guidance agenda for its Center for Drug
Evaluation and Research (CDER), listing dozens of guidance documents which plans to release during the 2014 calendar
year.
CATEGORY —Advertising
• Brief Summary and Adequate Information for Use: Disclosing
Risk Information in Consumer-Directed Print Advertisements and Promotional Labelling
for Prescription Drugs
• Considerations for Regulatory Submissions of Promotional Labelling
and Advertising Materials including Submissions in Electronic Format
• Direct-to-Consumer Television Advertisements – FDAAA DTC
Television Pre-review Program
• Internet/Social Media Platforms with Character Space
Limitations: Presenting Risk and Benefit Information for Prescription Drugs and
Medical Devices
• Internet/Social Media Platforms: Correcting Independent-Third
Party Misinformation About Prescription Drugs and Medical Devices
• Internet/Social Media Advertising and Promotional Labeling of
Prescription Drugs and Medical Devices – Use of Links
CATEGORY — Animal Rule
• Product Development Under the Animal Rule
CATEGORY — Biopharmaceutics
• Bioavailability and Bioequivalence Studies Submitted in NDA’s
or INDs for Orally Administered Drug Products – General Considerations
• Dissolution Testing and Specifications Criteria for
Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical
Classification System Class 1 and 3 Drugs
CATEGORY — Biosimilarity
• Biosimilars: Additional Questions and Answers Regarding
Implementation of the Biologics Price Competition and Innovation Act of 2009
• Clinical Pharmacology Data to Support a Demonstration of
Biosimilarity to a Reference Product
• Considerations in Demonstrating Interchangeability to a
Reference Product
• Labeling for Biosimilar Biological Products
• Reference Product Exclusivity for Biological Products Filed
Under Section 351(a) of the PHS Act
CATEGORY —Chemistry
• Allowable Excess Volume and Labeled Vial Fill Size
• Analytical Procedures and Methods Validation for Drugs and
Biologics
• Appropriate Package Type Terms for Injection Drugs or
Biological Products in Packaged in Multiple-Dose, Single-Dose, and
Single-Patient-Use Containers
• Specified Biotechnology and Specified Synthetic Biological
Products – Annual Report
• Comparability Protocols for Approved Drugs: Chemistry,
Manufacturing, and Controls Information
• Evaluation of Near Infrared Spectroscopy (NIR) Methods
• Immunogenicity- Related Considerations for the Approval of Low
Molecular Weight Heparin for NDAs and ANDAs
• Liposome Drug Products: CMC, Human Pharmacokinetic and
Bioavailability; and Labeling Documentation
CATEGORY —Clinical/Antimicrobial
• Attachment to Guidance on Antiviral Product Development –
Conducting and Submitting Virology Studies to the Agency: Guidance for
Submitting HIV Resistance Data
• Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated
Bacterial Pneumonia: Developing Drugs for Treatment
• Uncomplicated Gonorrhea: Developing Drugs for Treatment
CATEGORY —Clinical/Medical
• Chronic Fatigue Syndrome/Myalgic Enephalomyelitis: Developing
Drugs for Treatment
• 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
• Upper Facial Lines: Developing Botulinum Toxin Products
CATEGORY —Clinical Pharmacology
• Clinical Lactation Trials – Trial Design, Data Analysis and
Recommendations for Labeling
• General Clinical Pharmacology Considerations for Pediatrics
Studies for Drugs and Biological Products
• Pharmacokinetics During Pregnancy and the Postpartum Period –
Trial Design, Data Analysis, and Impact on Dosing and Labeling.
CATEGORY —Clinical/Statistical
• Multiple Endpoints in Clinical Trials
CATEGORY —Quality: Facility, Production and Process Control
• Contract Manufacturing Arrangements for Drugs: Quality
Agreements
• GXP Consideration for Outsourced IT (Cloud Computing) Systems
in Medical Product Manufacturing and Clinical Study Environments
• Interim Good Manufacturing Practice for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug and
Cosmetic Act
• Quality Systems Approach to Pharmaceutical Current Good
Manufacturing Practice
• Submission of Field Alert Reports and Biological Product
Deviation Reports
CATEGORY —Drug Safety
• Best Practices in Developing Proprietary Names
• Content, Format and Submission of Adverse Event Reports by
Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug and Cosmetic Act
• Over-the-Counter Pediatric Liquid Drug Products Containing
Acetaminophen
CATEGORY —Electronic Submissions
• Providing Regulatory Submissions in Electronic Format –
Submissions Under Section 745A of the Federal, Food, Drug and Cosmetic Act
• Providing Regulatory Submissions in Electronic Format –
Manufacturing Establishment Information
• Providing Regulatory Submissions in Electronic Format –
Postmarketing Safety Reports
• Providing Regulatory Submissions in Electronic Format –
Standardized Study Data
• Study Data Technical Conformance Guide and Data Standards
Catalog
CATEGORY —IND
• Adverse Events: Collection and Reporting for Secondary
Endpoints
CATEGORY —Labeling
• Indications and Usage Section of Labeling for Human
Prescription Drugs and Biological Products – Content and Format
• Labeling for Human Prescription Drug and Biological Products
Approved Under Accelerated Approval
• Pediatric Information: Incorporating into Human Prescription
Drug and Biological Products Labeling
• Pregnancy, Lactation, and Females and Males of Reproductive
Potential: Labeling for Human Prescription Drug and Biological Products –
Content and Format Requirements
• Product Title and Initial U.S. Approval in the Highlights of
Prescribing Information for Human Prescription Drug and Biological Products –
Content and Format
CATEGORY —Procedural
• Applying the Criteria for Requiring a Risk Evaluation and
Mitigation Strategy (REMS)
• Critical Path Innovation Meeting
• Division of Good Clinical Practice Compliance (DGCPC)
Requested Contents for New Drug and Biologic Applications to Facilitate BIMO
Inspection Planning and Conduct
• Drug Supply Chain Security Act (DSCSA) Implementation:
Identification of Suspect Product and Termination of Notifications of
Illegitimate Product for Finished Human Prescription Drugs
• DSCSA Implementation: Standards for the Interoperable Exchange
of Information for Tracing of Finished Pharmaceuticals Drugs
• Integrated Summary of Safety
• Investigational New Drug Applications Prepared and Submitted
by Clinical Sponsor Investigators
• National Drug Code (NDC) Assignment of CDER-Regulated Products
• Public Disclosure of FDA-Sponsored Studies
• Reporting Drug Sample Distribution Under Section 6004 of the Affordable
Care Act
• Reporting Licensure by Wholesale Drug Distributor and
Third-Party Logistic Providers
• Submission of Study Protocols for Drug Products with Certain
Risk Evaluation and Mitigation Strategies for Review by the Office of Generic
Drugs
• Survey Methodologies to Assess Risk Evaluation and Mitigation
Strategies (REMS) Goal Related to Knowledge
• Use of a Master File for Shared System Risk Evaluation and
Mitigation Strategies
• User Fees for Human
Drug Compounding Outsourcing Facilities Under Section 503B of the Federal,
Food, Drug and Cosmetic Act 
