Regulatory Affairs

In 2014, to date, FDA has issued 9 Warning Letters to firms for failure to pay their Generic Drug User Fee Act (GDUFA) fees. The latest two letters were issued on August 26, 2014, but were posted to the CDER web page on September 8 and 16, respectively.

In 2014, to date, FDA has issued 9 Warning Letters to firms for failure to pay their Generic Drug User Fee Act (GDUFA) fees. The latest two letters were issued on August 26, 2014, but were posted to the CDER web page on September 8 and 16, respectively.

On September 17, 2014, FDA hosted the GDUFA Public Hearing on Policy Development. With quite a few generic firms of all sizes represented at the hearing, a series of recurring themes appeared to resound. Lack of communication and transparency from FDA and ever growing facility fees that stifle entry of small new players were the loudest complaints from the audience.

n September 16, 2014, the Office of Generic Drugs (OGD) posted its final Guidance on Refuse-to-Receive (RTR) Standards and also published an ancillary draft Guidance entitled ANDA Submissions – Refuse To Receive Standards for Lack of Proper Justification of Impurity Limits (which explains that proper justification for specified identified impurities above qualification thresholds and specified unidentified impurities and unspecified [unknown] impurities with limits above identification thresholds must be included in the ANDA or it will receive an RTR letter).