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Guidance Agenda New & Revised Draft Guidances CDER Plans to Publish During Calendar Year 2018

FDA listed 106, either new or draft and/or revised draft guidances that it plans to issue in CY 2018.  This is quite an ambitious agenda!  This is a yearly exercise that FDA does and they have a tendency to come close to meeting their projections; be sure to review the entire list (here) to see if some of your interests will be met or augmented by some additional Agency guidance.

Below are a few categories and guidances that I find interesting.

Clinical/Medical

  • Opioid Dependence: Developing Depot Buprenorphine Products for Treatment
  • Opioid Dependence: Endpoints for Establishing Effectiveness of Medically Assisted

Generics

  • 180-Day Exclusivity: Questions and Answers
  • Assessing Adhesion for ANDAs with Transdermal Delivery Systems and Topical Patches; Revised Draft
  • Assessing Irritation and Sensitization Potentials of Generic Transdermal and Topical Patches Submitted in ANDAs
  • Bioequivalence Studies with Pharmacokinetic Endpoints for Drug Products Submitted in ANDAs; Revised Draft (What’s coming here?)
  • Failure to Timely Respond to an ANDA CR Letter (Will this provide a stricter interpretation than OGD has been applying? Will OGD still permit extensions from the one-year period outlined in the current regulation)
  • Referencing Approved Drug Products in ANDA Submissions; Revised Draft (Obviously, there may have been some comments that OGD is considering on the original draft.)
  • Sameness Under the 505(j) Pathway
  • Therapeutic Equivalence – General Considerations
  • Three-Year Exclusivity Determinations for Drug Products
  • Variations in Drug Products (ANDAs) Guidance (Could this provide more options for multiple drug variations that OGD will permit in the same application?)

Over-The-Counter

  • Innovative Approaches for Nonprescription Drug Products

Pharmaceutical Quality/Microbiology

  • Microbiological Considerations for Non-Sterile Drug Products (A topic of considerable debate between industry and FDA.)

Pharmaceutical Quality/CMC

  • Clarification of Human Drug Application Establishment Information Q&A Guidance (Will this deal with the issue of phantom establishments?)
  • Harmonizing Compendial Standards with Drug Application CMC Approval Requirements Using the USP Pending Monograph Process
  • Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products – Chemistry, Manufacturing, and Controls Documentation; Revised Draft
  • Post-Approval Changes to Drug Substances (GDUFAII)
  • Use of Liquids and/or Soft-Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments
  • Using the Inactive Ingredient Database

Pharmaceutical Quality/Manufacturing Standards (CGMP)

  • CGMP Final Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Revised Draft
  • Field Alert Report Submission (It always amazes me that there are still questions about when to issue a field alert report but maybe this guidance will help answer this question.)

Procedural

  • Content of Threshold Analyses and Human Factors Submissions to an NDA, BLA or ANDA
  • Designated Delivery Services for 505(b)(2) or ANDA Applicants Sending Notices of Paragraph IV Patent Certification

Remember that this is just a preview of what I find interesting. Please take some time to peruse the entire list to see what you may be looking for and what is relevant to your firm.