On Friday January 22, CDER issued its yearly document outlining what Guidance documents it hopes to issue in 2016.  This yearly wish list is always a highlight of the beginning of every calendar year.  The document identifies either new guidance documents FDA hopes to release, as well as those it plans to revise.  This year the guidance agenda has 15 different categories and lists 102 different guidance documents it hopes to issue this year.  That’s lots of reading to fit into your schedule!

In this post (and future posts), we will concentrate on issues believed to be the most significant and important.  While I may not always get them all right or miss a few biggies, I hope to target the documents I believe may be the most important in terms of enhancing industry knowledge in regard to FDA expectations.

The full list of proposed documents FDA is working on may be found here and those picked to be highlighted here may, when appropriate, be accompanied by some editorial comment.


  • 180 Day Exclusivity: Guidance for Industry

This may be one of the most interesting of the guidance documents issued and will likely provide insight and examples of some of the more complex 180-day determinations and will also likely outline consolidated FDA thinking when it comes to both the award and forfeiture of 180-day exclusivity.

  • ANDA Submissions – Content and Format of Abbreviated New Drug Applications; Revised Draft

In discussions relative to GDUFA I and now GDUFA II negotiations, many in industry has complained that OGD has created a moving target relative to ANDA submission and approval requirements.  Could this revision of this document represent a more comprehensive outline of ANDA requirements that industry has been begging for?

  • ANDA Submissions – Identifying Reference Products

This document could help the age old question of what RLD do I reference in my ANDA, at least we hope that is the genesis of this new guidance document.

  • ANDA Submissions Refuse to Receive Standards: Questions and Answers

We already have a Q&A document on these standards but there has been lots of clarification questions industry has asked that may be addressed.  Had OGD changed its mind on some issues? We will need to wait and see.

  • Assessing Adhesion for ANDAs with Transdermal Delivery Systems and Topical Patches

Always a question because each transdermal system may behave differently on different patients.  The generic may have better adhesion on a patient that the brand won.

  • Determining Whether to Submit an Application Under 505(b)(2) or 505(j)

While this appears to be a simple concept, often the decision is driven by very complicated issues.  This guidance will help firms save time in making the correct filing decision by giving concrete examples that have caused firms problems in the past and give helpful advice on making the right decision.

  • General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products

Here is one many people have been waiting for.  This guidance hopefully will shed some light on when generic version of abuse deterrent innovator products can be considered the “same as” the reference listed drug.  We hope OGD gets into the weeds on this one because there are so many questions.

  • Issuance of ANDA Complete Response Letters Before Completion of Review by One or More Disciplines

Sounds like the old discipline review letter – well maybe it is!

  • Three-Year Exclusivity Determinations for Drug Products

Again sounds simple as we all know that for an NDA to be eligible for 3-year exclusivity, they must have new clinical studies, other than bioequivalence studies, and that the studies must be essential for approval of the product, new use or labeling.  Well nothing is ever as simple as it seems, and this guidance document has been in the works for a long time.  Look for some potentially very interesting discussions in this document when it issues.

  • Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn

Who has this responsibility?  With the FDA surprise labeling rule still being evaluated and in this post-Mensing era, the content of this document may offer some surprising guidance.  Right now under the current regulatory scheme, it is the FDA that is required to dictate changes in this circumstance.  Who knows what FDA is likely going to say about this.

Well those are some of the generic guidance documents that FDA hopes to issue this year.  Some are heavyweights and others may be just for clarification.  Here is a suggestion for FDA that would help both FDA and industry in dealing with revised guidance documents.  FDA, please highlight what has changed in the document – like us in industry have to do when we change an SOP.  Tell us where the revisions are!  Thanks that would help a lot!  This blogger will cover more of the proposed guidance documents in future posts.  But remember – these are just my best guesses.