macro shot of flying bee swarm after collecting pollen in spring on green bokeh

What’s Coming for Guidance in 2020?

The FDA released its most current version, its “Guidance Agenda: New & Revised Draft Guidances: CDER Plans to Publish During Calendar Year 2020,” yesterday and there are some interesting things for generic and new drugs.  The complete document can be viewed here, but we will highlight some of what we believe might be the most interesting of the bunch.

CATEGORY – Generics

  • Expect another revision to the 180-day Exclusivity Q&A document.
  • There are two guidances coming of refuse-to-file (RTR) issues, one on DMF facility deficiencies and one on RTR standards.
  • There are a number on bioequivalence issues, including adhesion for transdermal systems, and irritation and sensitization studies, and it looks like a general update regarding BE studies with pharmacokinetic endpoints, as well as one on evaluation of therapeutic equivalence, and more on the handling of BE samples.
  • Looks like the FDA might get tougher on the timing of responses to complete response letters if firms fail to respond in the regulatory timeframe (which is now one year).
  • Another Orange Book Q&A document is in the works.
  • Revising labeling after the RLD label changes.
  • Q3 of topical dermatological products, which may pave the way for more BE waivers of in vivo studies.

CATEGORY – Over-the-Counter Drugs

  • New guidance for annual reportable changes for OTC NDA and ANDA products.

CATEGORY — Pharmaceutical Quality/CMC

  • Another revision to the stability testing of drug substances and drug products for ANDA Q&A documents – what else is new? But, also, there is going to be a guidance on labeling considerations for associated drug products.
  • A guidance on in vitro testing and labeling of drug products administered via enteral feeding tubes. (Remember the product withdrawal for a generic product that swelled and blocked a feeding tube!)
  • With all the recalls for visual particulate matter in parenteral products over the last few years, the Agency will issue a guidance on visual inspection of such products.

CATEGORY – Procedural

  • Yet another guidance on designated delivery services for PIV certifications. I think they may be adding pony express to the long list of currently acceptable methods!
  • A guidance on notification of permanent discontinuation of a drug or biologic product.
  • And a guidance on risk management plans to mitigate drug shortages.

This is just a brief preview of the eighty-eight new and revised Guidances the Agency has on its agenda for 2020.  We know the number issued will be less than that but keep an eye out because it looks like a busy year for guidance advice from the FDA.  Keep up with the buzz surrounding this agenda.