On January 31, 2022, CDER released its Guidance Agenda for new and revised guidances expected to publish in 2022. While the list is somewhat aspirational, it provides a window into what the Center is working on and what we might see this year.  The document lists 98 new and revised guidance and can be found here. As usual, the document is broken down into different categories of document types.  This year, there are guidance documents covering 17 different categories by topic.  Once again, I have slogged through the list and have picked my favorites for the year (with comment where appropriate!).

Biosimilars

  • Product Class-Specific Recommendations for Developing Biosimilar and Interchangeable Biological Products – the more information on interchangeability the FDA can put out, the more help sponsors will have in figuring out how to tackle this issue.

Clinical/Medical

  • Development of Non-Opioid Analgesics for Acute Pain – With the opioid crisis still causing havoc and death, searching for more non-opioid products appears to be where the needle is pointing. (Also, interesting to note on this topic is that the first single entity hydrocodone ER product [Zohydro] has been withdrawn by the NDA holder.)
  • Meeting the Substantial Evidence Standard Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence – Could this be a game changer?  I think likely not, as there must be some very specific instances where this might occur.

Compounding

  • 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 – This revision is coupled with a separate revision for 503B outsourcing compounders. It will be interesting to see where the FDA lands on this issue.
  • Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act – Not surprising that the Agency plans on addressing this issue as the potential to move from compounding to full commercial scale manufacturing with product slipping into the wholesale supply chain could be a door FDA might want to shut before it opens more. Just guessing on this one, but I would not expect it to turn out differently.

Generics

  • ANDA and NDA Submissions: Data Integrity for BA/BE Studies at Testing Sites – Not surprising given the issues with data integrity uncovered at two CROs over the last year and the continuing DI problem in general.
  • ANDA Submissions – Refuse-to-Receive for DMF Facilities Deficiencies – Look out for this one! Could it spell trouble for ANDAs where the DMFs are found to be out of compliance at time of ANDA submission?
  • Handling and Retention of BA and BE Testing Samples – This issue has been beat to death ever since the generic drug scandal in the late 80’s; where is this one going?
  • Pediatric Exclusivity General Considerations for ANDAs – Is there a new twist coming?
  • Three-Year Exclusivity Determinations for Drug Products – Will this be a new angle on how the Agency makes determination, because three year-exclusivity has been described in various guidance and MaPPs.
  • Waivers for pH Adjusters in Drug Products Intended for Parenteral, Otic, and Ophthalmic Use This is one guidance that everyone who manufacturers these types of products has been asking about and waiting for.

OTC Drugs

  • OTC Monographs Order Requests (OMORs) – Format and Content of Data Submissions – The new program tries to get its policies in place and describe the how, what, and where for the new OTC administrative order process.

Pharmaceutical Quality/CMC

  • Stability Considerations for Drug Substances and Drug Products in NDAs, ANDAs, and BLAs and Associated Labeling Statements for Drug Products – The issues that are likely to be discussed in this guidance and the one directly below appear to me to have been covered in ICH stability guidance and FDA guidances. Maybe there is a new issue that FDA will be identifying in these guidances that I am unfamiliar with.
  • Stability Recommendations for Additional Manufacturing Facilities in NDAs, ANDAs and BLAs, and Additional Drug Substance Sources in NDAs and ANDAs

Procedural

  • Charging for Investigational Drugs Under an Investigational New Drug Application – Questions and Answers – Nothing like a good Q&A document to resolve common issues of potential misunderstanding or confusing guidance.
  • Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements – Maybe FDA is putting more teeth into its program, especially with some of the high profile Accelerated Approval issues and withdrawn applications and supplements. Timely submission of post marketing confirmatory studies is not only on FDAs mind but certainly on the minds of congressmen.
  • Exclusivity for First Interchangeable Biosimilar Biological Product – Interchangeable biosimilars are receiving a lot of attention after the first few have been approved. Now it is time for FDA to discuss how the exclusivity provisions will work.

Those are the guidance documents that hit my top 17 for 2022!  Don’t hold your breath for all of them, but also, get ready to put on your reading glasses as they start to be issued by FDA this year.