New & Revised Guidance Agenda for Calendar 2015
Written by Garth Boehm January 09, 2015
On January 6th FDA published the new and revised guidance agenda for calendar year 2015. As they say, this is a list of new guidances and revisions to existing guidances that are “under development” at the date of issue of the list. Now guidances were introduced by FDA as a faster way of issuing “non-binding” guidance that is of use to BOTH sponsors and FDA personnel. As they say, guidance represents the Agencies current thinking, meaning it could change in the future. Faster is also a relative term, some guidances “under development” move from year to year. Nevertheless, guidance is good, very good.
In calendar 2014 the Guidance Agenda listed 70 guidances either new or to be revised. 61 of these happened during the year, an excellent result. The 2015 agenda lists 91 guidances. Let's hope that the excellent results of 2014 are carried into 2015.
For generic sponsors, there are a few proposed guidances that are of particular interest. Under Biopharmaceutics the Food Effect guidance is to be revised, it was last worked on in 2003. A pair of guidances, Dissolution Testing and Specifications for IR dosage forms in BCS class 1 and 3 and Waiver of In Vivo BE based on BCS are listed for issue/revision. It is rumored that BCS class 1 and 3 will be eligible for waiver and these two guidances will define the requirements for this waiver.
There are guidances of relevance for labeling and electronic submissions as the Agency moves towards compulsory electronic submissions.
Under the heading “Generics” there are 4 guidances that all address subjects that have current guidance, we will watch to see what might be in these revisions.
In the new Pharmaceutical Quality/CMC heading 4 that catch the eye are Elemental Impurities, Microbiological Quality in Non-sterile Drug Product manufacturing, Quality Metrics and Risk-Based inspections (not under cGMP anymore!), and an intriguingly titled “Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products”.
The other related new heading, Pharmaceutical Quality/Manufacturing Standards (CGMP) is listed “CGMP Data Integrity Questions and Answers” will no doubt be of interest given the current wave of data fraud inferred in Warning Letters.
Other guidances of interest include:
Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate
Public Disclosure of FDA-Sponsored Studies
Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs
Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS)
Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base
