In February 2014, then FDA Commissioner Margaret Hamburg issued a memorandum directing all Centers and the Office of Regulatory Affairs (ORA) to develop a plan for more collaboration and efficiency in operations. As a result of this mandate, the Centers and ORA have developed fiscal year plans to move toward a distinct commodity-based, vertically-integrated regulatory structure.
The FDA recently issued a draft Guidance document; entitled “Control of Elemental Impurities in Drug Products”. This document provides guidance in light of the issuance of ICH Q3D Elemental Impurities and USP<232> Elemental Impurities – Limits and USP<233> Elemental Impurities – Procedures. USP <232>.
FDA’s drug shortage list has a total of 60 drug products in the “currently in shortage” status (see list here). As you can see from the table below, injectable products are leading the list with 46 drug products currently in shortage.
The second leading category are solid oral dosage forms and then just a few other dosage forms occupy the list as still in a shortage situation.
Back in January 2016, we posted a blog that described a revision in the bioequivalence (BE) Guidance for Paliperidone Palmitate extended-release suspension for intramuscular use (here). That draft Guidance revision was dated December 2015, just a few months ago. Now another revision takes its place.
Some interesting changes are noted.