Looks like we all will be doing a lot of reading and assimilation of new information in 2021.  The CDER Guidance Agenda – New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2021 contains 105 new and revised guidance documents that CDER plans to release this year.  While there are a number of carry-over guidances from the 2020 list, there are a lot of new material that could revise the way CDER components do business and either provide new or revised Agency expectations in a number of areas.

While you may review the entire list here, I will provide some of my top hits in the guidance parade from some of the 18 different categories along with my brief observations.


  • Product Class-Specific Recommendations for Developing Biosimilar and Interchangeable Biological Products (Are we getting close to our first interchangeable Biosimilar? Hopefully, this guidance will provide some clues!)


There are three guidance documents in this category, but I can let you know that even when I read the titles, they make my head want to explode!


  • Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications (This gets me a bit nervous, as when things happen in the NDA world they have a tendency to trickle down to generics – you know the old “same as” requirements.)


  • Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft
  • Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Revised Draft (it will be interesting to see the revisions made to these two guidance documents, which may be due ,in part, to FDA’s legal loss on a specific case regarding a compounded version of a commercially available approved product.)
  • Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors – Guidance for Outsourcing Facilities Under Section 503B of the FD&C Act (A needed addition to the compounding guidance tsunami to assure proper labeling and avoid ADEs from medication errors.)

Generics (my favorite)

  • ANDA Submissions – Refuse-to-Receive for DMF Facilities Deficiencies (This is a recent hot topic as I was recently made aware of an ANDA getting a Refuse-to-Receive [RTR] action based on a facility that was under an OAI compliance status. This is the first I have ever seen since the generic drug scandal in the late 80’s and the basis of those RTRs was fraud.  Pay close attention to this as an RTR costs you 25% of the ANDA filing fee!)
  • ANDA Submissions – Refuse-to-Receive Standards: Questions and Answers (Again, new Q&As added? Important to see if that is related to the above guidance.)
  • Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs; Revised Draft (Whoop – there it is!)
  • Evaluation of Therapeutic Equivalence (So what surprises can this document hold?)
  • Waivers for pH Adjusters in Drug Products Intended for Parenteral, Otic, and Ophthalmic Use (Here is an interesting one! Can it be that OGD does not like the regulations any longer?  What will these waivers entail?  Will it open or close doors? Stay tuned!)
  • Handling and Retention of BA and BE Testing Samples (This has been an ever-evolving issue since the passage of Hatch-Waxman. What direction will this document take us?)
  • In Vitro Permeation Tests for Semi-solid Topical Products Submitted in ANDAs
  • In Vitro Release Tests for Semi-solid Topical Products Submitted in ANDAs (This, and the document above, could mean a new approach (paradigm) for testing of semi-solids.)
  • Physico-Structural (Q3) Characterization of Topical Dermatological Drug Products Submitted in ANDAs (And this one as well! Get ready for changes – could there be a side stepping of in vivo studies based on these three topical guidances?)

Over-the-Counter Drugs

  • Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products (Will this permit additional reduction of regulatory burden for approved OTC products?)

Pharmaceutical Quality/CMC

  • Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross Contamination (This is something that has long been discussed and seldom accomplished – can’t wait to see what the compliance folks say about this one.)
  • Inspection of Injectable Products for Visible Particulates (given the literally hundreds of recalls for this issue over the last few years, I am sure there will be attention from injectable manufacturers who will be anxious to explore the contents of this document.)


  • Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements (After so much talk, is the hammer finally coming down?)
  • Exclusivity for First Interchangeable Biological Product (Is this another hint at the first interchangeable biosimilar coming soon?)
  • Reporting Amount of Distributed Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Something new here?)

These are just a few of the many guidances which may prove interesting.  But who knows what gems may be buried in the others?  Busy year ahead!