New or Revised Guidances to Look for From FDA in Calendar Year 2015

FDA issued a Guidance today entitled “Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015”.  This document gives us an idea of what is new and what changes we can expect on various issues over the coming year.  It is not specific as far the specific changes that are upcoming, but at least it provides direction as to where changes or new advice may be forthcoming from FDA.

While the complete document can be found here ,I would like to point out the following areas where changes are upcoming that may be of specific interest to readers.  The document outlines 8 advertising, 4 biopharmaceutics, 4 biosimilar,  11 clinical/medical, 9 clinical pharmacology, 1 clinical statistical, 3 drug safety, 3 electronic submission, 4 generic, 3 labeling, 13 quality chemistry, manufacturing,and control (CMC), 3 cGMP, 1 pharmacology/toxicology, and 26 procedural Guidances the Agency is in the process of preparing.  Some of particular interest are described below:

CATEGORY —Generics

• Acceptability of Draft Package Insert Labeling to Support ANDA Approval

• ANDA Submissions Refuse-to-Receive for Typographical Errors and Misplaced Files

• Complete Assessments for Type II API DMFs Under GDUFA

• Guidance for Industry on GDUFA Completeness Assessment Checklist for Type II API DMFs

An observation on the Generics category – Each of these issues has been previously addressed in prior guidances issued by the Office of Generic Drugs (OGD); however, it appears that some of these issues might be revisited and expanded as OGD learns from its experiences under the GDUFA program and searches for additional quality measures.

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

• Food Effects Bioavailability and Fed Bioequivalence Studies

• Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System

Here is another category where these issues have been addressed in previous Agency guidance documents, so we will look for the changes and differences when these documents issue during the year.

CATEGORY Biosimilarity

• Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

• Considerations in Demonstrating Interchangeability to a Reference Product

• Labeling for Biosimilar Biological Products

• Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

With the FDA having accepted numerous biosimilar application over the last year, some of these Guidance documents are going to be key to the success of the biosimilar program especially issues regarding interchangeability of biosimilar and labeling.

Other Guidances that may be of specific interest (and that we hope may answer a number of outstanding and ongoing questions) are as follows:

  • Quality Metrics and Risk-Based Inspections
  • Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
  • Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products
  • Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft
  • For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B
  • Submission of Field Alert Reports and Biological Product Deviation Reports

There are likely to be some important changes coming this year and we know how the Agency likes to keep the bar high, so let’s watch to see where FDA may be going on these and other important issues this year.