It’s Official – A New Guidance Document for Analytical Method Validations


Last week, the FDA released a Guidance entitled Analytical Procedures and Method Validations for Drugs and Biologics (here)  which replaces the 2000 Draft Guidance document Analytical Procedures and Method Validation” and the 1987 Guidance document “Guidelines for Submitting Samples and Analytical Data for Methods Validation”.

GDUFA Fees Announced for FY 2016 – Surprise, Surprise!

The new GDUFA fees for 2016 were published today in the Federal Register (here) and there were some real surprises.  For instance, the ANDA fee (that we thought was going to decrease given the fact that 2014 saw a record 1465 ANDAs submitted) soared and apparently FDA is justifying that the fee increase is due to the lower number of ANDAs that have been submitted so far in 2015 (377 through June 2015 with a straight line projection at that rate of 502 to be submitted in FY 2015).

Quality Metrics Draft Guidance Issues

Today, the FDA released its draft Guidance entitled, “Request for Quality Metrics.” The document outlines the FDA’s thinking on the use of quality metrics data “to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.”

Special Termination of Debarment for One FDA Reviewer is Granted

In a Federal Register Notice today, the FDA announced the termination of permanent debarment of David Brancato.  David was one of the original FDA staff members implicated in the Generic Drug scandal.  He was originally debarred on January 6, 1994.

Special termination of debarment can occur when there is a determination that an individual substantially assisted in and cooperated with authorities in the investigation. 

Where Do These Guys Come From?

In a series of FDA Safety Alerts, Recall Notices, and Enforcement Actions over the last couple of years, the Agency has notified consumers of dozens of OTC products that contain undeclared and dangerous drugs.

CMC Draft Guidance to Better Define Changes That Must Be Reported to FDA – Clear as Mud

Industry does not always get either the filing type or the need to file the change correct and, sometimes, due to an overabundance of caution, makes supplemental submissions when they may be able to either report the changes in an Annual Report or may not need to report the change at all, but manage it under their Pharmaceutical Quality System (PQS).