Regulatory Affairs

Today, FDA published its final guidance on New Chemical Entity (NCE) Exclusivity Determinations for Certain Fixed-Combination Drug Products. The Guidance comes about 7.5 months after the February 2014 Federal Register notice first announcing the new Agency position was published. While some parties are happy with the decision to award NCE exclusivity if one of the components is a first time approval (the previous Agency position was that if one component had been previously approved, then the combination was not eligible for the 5-year protection), others are crying in their soup (and in Federal Court) about the change.

With a record number of ANDAs received by the Office of Generic Drugs (OGD) and a modern day record low number of approvals, we move into FY 2015 still looking for the bright spot.

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.