FDA Publishes List of Guidances Scheduled for 2016

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-27-2016 06:29


The US Food and Drug Administration (FDA) published its guidance agenda for calendar year 2016 and identified the new and revised draft guidances that FDA's Center for Drug Evaluation and Research plans to publish during calendar year 2016. The list includes guidances on biosimilarity, chemistry, manufacturing and controls (CMC), manufacturing and quality, including on data integrity, and generics. Agenda items reflect draft and revised draft guidances under development as of January 22, 2016.

FDA said it plans to issue three guidances relating to 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.

FDA plans to issue 12 guidances relating to generic drugs:
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 Withdr

The agency plans to issue the following guidances relating to pharmaceutical quality and manufacturing standards:
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

Additionally, the agency plans to issue the following guidances relating to pharmaceutical quality and 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

Among its procedural guidances, the FDA plans to issue several guidances relating to the the Drug Supply Chain Security Act (DSCSA), which outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

Source: FDA


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