2016 FDA Guidances Focus on Data Integrity and Quality Standards

2016 FDA Guidances Focus on Data Integrity and Quality Standards

The FDA has updated its list of scheduled guidances for the calendar year 2016, with a major focus on pharmaceutical quality, data integrity and generics. There are 102 planned guidances this year, compared with 92 last year.

In pharmaceutical quality manufacturing standards, three guidances are planned on the following topics: GMP data integrity, expiration dating for repackaged products and repackaging of products by pharmacies and outsourcing facilities.

CDER Director Janet Woodcock also has tapped generic pharmaceuticals as a significant area for the agency. This year’s priority list seems to reflect that commitment, as there are a dozen guidances in that area planned for 2016.

Industry also is anxiously awaiting guidance on biosimilars, and CDER has three documents on the topic in the works: one detailing the agency’s thinking on demonstrating interchangeability with a reference product, one on biosimilar labeling and another on statistical approaches to evaluating similarity of biosimilars.

In addition, six guidances are planned for the FDA’s new track-and-trace rules, which are already in effect for drugmakers. Pharmacies have been given numerous deadline extensions to implement the new drug-tracking standards.