Insights from Atypical Actives Workshop Could Drive Needed Technical/Regulatory Guidance, Participants Affirm

The insights that emerged at a PDA/FDA workshop on atypical active ingredients could form the basis for guidance that would clarify the regulatory expectations involved and help close the existing communication gaps in the manufacturing and distribution chain.

The two-day workshop, held in early March in Bethesda, Maryland, brought together the industry and regulatory players involved to develop a clearer understanding of the issues and a road map of how to address them when ingredients commonly used as excipients take on the role of an active ingredient in the dosage form.

Two central themes that emerged during the workshop were: ● the lack of communication and understanding between the players of the issues involved, and ● the need for clear expectations that both industry and regulators can agree upon.

The FDA participants recognized the gaps in their own understanding that the workshop was helping to fill.

“I definitely want to be sure that FDA is aware of this,” CDER Office of New Drugs Quality Assessment (ONDQA) Reviewing Chemist Jeffrey Medwid commented.  “I do not think it was really that hot of a topic until this [workshop] came along.”  He added that the other FDA attendees will be interacting with higher management on the issue as well.

[The insights and recommendations from the workshop are analyzed for subscribers here.  See the IPQ “In the News” March 21 companion story for more on the challenges in the relationships and communication gaps in the producer/user/regulator chain when atypical actives are involved. Non-subscribers can purchase the stories for $95 each by contacting Karen Bertani ( For subscription/license information click here.]