U.S. Food and Drug Administration News

In mid-January 2015, the U.S. Food and Drug Administration (FDA) announced the formation of a new Office of Pharmaceutical Quality (OPQ). The office is intended to centralize and standardize drug quality oversight. Starting immediately, all new drug applications will now be reviewed by OPQ using a “quality scorecard.” This includes applications for generic drugs, new drugs, and over-the-counter (OTC) products. Pharmaceuticals that were already under review will not transition to the new office.

FDA officials have stated that the OPQ will look closely at the quality of a company’s manufacturing facility and processes, requiring information such as compliance with good manufacturing practices (GMP). According to the FDA, drug companies that submit high quality data should see more predictability in their applications and even speedier approvals.

The OPQ is planning to release a guidance document later this year explaining the specific metrics the FDA will be focusing on in the review process. Pharmaceutical manufacturers should expect increased communication with the FDA as well as a more integrated review process for all drug product areas and all manufacturing sites — foreign and domestic.

The FDA has also developed a one-stop database of all FDA guidance documents. Previously, these documents were located on various pages of the FDA website and were not necessarily always replaced with updated versions. The new database also offers helpful search features, such as searching by FDA office or by type of product, as well as links to related FDA documents and information.