The FDA announced some additions (**) and revisions to titles (*) of Guidance documents it plans to release in 2016.  We have posted on this list previously (here) (and here) and highlighted this blogger’s impression of some of those proposed Guidance documents.  Well, FDA has published another revised list and here are the changes:

  • Comparative Analyses of the Device Constituent of a Drug-Device Combination Product Submitted in an ANDA ** – A highly anticipated guidance as drug-device combinations of generic products are in the news today. This guidance may provide more clarity of how the FDA wants a firm to outline how their product is comparable to the reference listed drug.
  • Elemental Impurities in Drug Products*
  • Data Integrity and Compliance with CGMP*
  • Submission of Quality Metrics Data; Revised Draft** – while the two “*” indicate this is a newly added guidance according to the legend, the fact that FDA states it is a revised draft is a bit confusing.
  • Certification Process for Designated Medical Gases*
  • Government Public Health and Emergency Response Stakeholders: Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles*

The list, as noted before, is very aggressive, as there are a lot of Guidance documents cited that we expect to see this year. While many have been issued, there are many more we anxiously await.  Each document will shed additional light on FDA expectations and will, thus, help industry “get it right the first time.”   The full updated list can be found here.