FDA’s CDER Announces New & Revised Draft Guidances it Plans to Publish in 2016


On Friday, January 22, FDA’s Center for Drug Evaluation and Research (CDER) published its 2016 guidance agenda. The guidance agenda is published on an annual basis and announces the draft guidances that the Center plans to publish during the 2016 calendar year. The agenda, which sheds light on what CDER plans to focus on throughout the year, places an emphasis on the clinical aspects of drug development, pharmaceutical quality, generics, and various procedural activities.

The agenda is organized into categories and includes the following topics:

Advertising:

  • Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
  • Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites
  • Manufacturer Communications Regarding Unapproved, Unlicensed, or Uncleared Uses of Approved, Licensed, or Cleared Human Drugs, Biologics, Animal Drugs and Medical Devices
  • Presenting Risk Information in Prescription Drugs and Medical Devices Promotion; Revised Draft

Biopharmaceutics:

  • Bioavailability and Bioequivalence Studies Submitted in NDA’s or INDs for Orally Administered Drug Products – General Considerations
  • Food Effects Bioavailability and Fed Bioequivalence Studies

Biosimilarity:

  • Considerations in Demonstrating Interchangeability With a Reference Product
  • Labeling for Biosimilar Products
  • Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

Clinical/Antimicrobial:

  • Anthrax: Developing Drugs for Prophylaxis of Inhalation Antrax
  • Attachment to HIV-1 Infection: Developing Antiretroviral Drugs for Treatment – Guidance for Submitting Clinical Trial Data Sets
  • Bacterial Vaginosis: Developing Drugs for Treatment
  • Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment; Revised Draft
  • Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention
  • Vulvovaginal Candidiasis: Developing Antimicrobial Drugs for Treatment

Clinical/Medical

  • Allergic Rhinitis: Developing Drugs Products for Treatment; Revised Draft
  • Exocrine Pancreatic Insufficiency Drug Products: Submitting Marketing Applications and Recommendations for Labeling
  • Guidance for clinical Investigators and Sponsors Natural History Studies for Rare Disease Drug Development
  • Measuring Treatment Benefit in Pediatric Populations: Use of Clinical Outcome Assessments
  • Nonallergic Rhinitis: Developing Drug Products for Treatment • Pediatric Oncology Product Development; Revised Draft
  • Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
  • Qualification of VVSymQ Instrument for the Measurement of Varicose Vein Symptom Burden in Patients with Superficial Venous Incompetence
  • Qualification of the Evaluating Respiratory Symptoms (E-RS) in COPD a Patient Reported Outcome
  • Ulcerative Colitis: Developing Drugs for Treatment

Clinical Pharmacology:

  • Clinical Drug Interactions Studies: Study, Design, Data Analysis, Implications for Dosing and Labeling Recommendations, Revised Draft
  • Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling; Revised Draft
  • In vitro Metabolism-and-Transporter Mediated Drug-Drug Interaction Studies; Revised Draft
  • Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling; Revised Draft
  • Pharmacokinetics During Pregnancy and the Postpartum Period – Trial Design, Data Analysis, and Impact on Dosing and Labeling; Revised Draft
  • Population Pharmacokinetics

Clinical/Statistical:

  • Adaptive Design Clinical Trials for Drugs and Biologics; Revised Draft
  • Meta-Analysis of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biologic Products
  • Multiple Endpoints in Clinical Trials

Drug Safety:

  • Format and Content of Proposed Risk Evaluation and Mitigation Strategies
  • Postmarketing Safety Reporting for Human Drugs and Biological Products Including Vaccines

Electronic Submissions:

  • NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions
  • Providing Regulatory Submissions in Electronic Format – Submission of Manufacturing Establishment Information
  • Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards
  • Providing Regulatory Submissions in Electronic Format – Standardized Bioanalytical Data

Generics:

  • 180 Day Exclusivity: Guidance for Industry
  • ANDA Submissions – Content and Format of Abbreviated New Drug Applications; Revised Draft
  • ANDA Submissions – Identifying Reference Products
  • ANDA Submissions Refuse to Receive Standards: Questions and Answers
  • Assessing Adhesion for ANDAs with Transdermal Delivery Systems and Topical Patches
  • Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in ANDAs
  • Determining Whether to Submit an Application Under 505(b)(2) or 505(j)
  • General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products
  • Issuance of ANDA Complete Response Letters Before Completion of Review by One or More Disciplines
  • Submission of ANDAs for Certain Highly Purified Synthetic Peptide Drug Products
  • Three-Year Exclusivity Determinations for Drug Products
  • Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn

Labeling:

  • Child Resistant Closures and Labeling
  • Gluten in Drug Products and Labeling Related to Celiac Disease
  • Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format
  • Labeling for Combined Hormonal Contraceptives
  • Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format

Pharmaceutical Quality/CMC:

  • Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products; Revised Draft
  • Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information; Revised Draft
  • CMC Postapproval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports
  • Drug Master Files; Revised Draft
  • Elemental Impurities in Drug Products Marketed in the United States
  • Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process
  • In-vitro Methods for Evaluation of Abuse Deterrent Properties of Opioid Products
  • Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry, Manufacturing, and Controls Documentation; Revised Draft
  • Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing
  • Nanomaterials in Drug and Biologic Products
  • Quality Metrics Technical Conformance Guide
  • Regulatory Classification of Pharmaceutical Co-Crystals; Revised Draft
  • Specified Biotechnology and Specified Synthetic Biological Products – Annual Report
  • Type V Drug Master File (DMF) for Combination Products with CDER Jurisdiction Utilizing a Device Part with Electronics or Software
  • Use of the FDA Inactive Ingredient Software (IID)
  • Quality Attribute Considerations for Chewable Tablets

Pharmaceutical Quality/Manufacturing Standards (cGMP):

  • CGMP Data Integrity Questions and Answers
  • Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft
  • Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities

Pharmacology/Toxicology:

  • Nonclinical Evaluation of Agents Used in the Treatment of Osteoporosis

Procedural:

  • Applying the Statutory Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS)
  • Certification Process for Designated Medical Gases*
  • Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
  • Designated Delivery Services for 505(b)(2) or ANDA Applicants Sending Notices of Paragraph IV Patent Certification
  • DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and ThirdParty Logistics Providers
  • DSCSA Implementation: Products Eligible for Grandfather Status
  • DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices
  • DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
  • DSCSA: Verification Systems for Prescription Drugs
  • DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements
  • Field Alert Report Submission
  • How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable Risk Evaluation and Mitigation Strategies for RLD
  • Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate
  • Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009.
  • National Drug Code (NDC) Assignment of CDER-Regulated Products
  • Pediatric Product Development in the Context of the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals Act (BPCA); Revised Draft
  • Pediatric Study Plans: Content of and Process for Submitting Initial PSP and Amended PSP; Revised Draft
  • Public Disclosure of FDA-Sponsored Studies
  • Regulatory Considerations: Complying with the Pediatric Research Equity Act (PREA) & Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals Act (BPCA); Revised Draft
  • REMS Assessment: Planning and Reporting
  • Special Protocol Assessment
  • State and Local Government Public Health and Emergency Response Stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules for Strategic Stockpiles
  • Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge
  • Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
  • Use of Electronic Health Records Data in Clinical Investigations

In its announcement, CDER states that items included in the agenda reflect original and revised draft guidances that were being developed when the agenda was published. Furthermore, CDER is not bound by this list of topics, required to issue a guidance on every topic listed, or precluded from developing guidances on topics other than those included within the list.