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GPhA Webinar: OPQ's New "Real Time" Communication Plan for 2015

Timely and meaningful communications between FDA and industry is a critical component of an efficient review process. Industry, FDA and consumers will benefit significantly by effective communication practices that may lead to shortened approval times. In an effort to promote enhanced communications CDER’s Office of Pharmaceutical Quality is working to facilitate more “real time” interactions with industry.

In his presentation at this year’s GPhA Fall Technical Conference, Dr. Lawrence Yu indicated that the Office of Pharmaceutical Quality (OPQ) has rolled out “real time” communications during the review of the chemistry, manufacturing, and controls (CMC) portions of all original ANDA submissions received on or after October 1, 2014. OPQ’s new communication practices will provide industry with a significant opportunity to respond in “real time” to regulatory comments and/or questions.

Key OPQ leaders will provide an overview of the new communication plan as well as details about what ANDA applicants can expect as the new communication paradigm is implemented by OPQ.

The following key OPQ leaders will be presenting:

  • Susan Rosencrance, Acting Director, the Office of Lifecycle Drug Products, will provide an overview of the new plan.
  • Glen Smith, Acting Deputy Director, the Office of Lifecycle Drug Products, will provide an overview of the review process.
  • Robert (Bob) Gaines, Acting Director, Division of Regulatory and Business Process Management II, Office of Program and Regulatory Operations, will provide an overview of the Project Management process.


Click Here to review FDA's slides from the GPhA-FDA Webinar on Real Time Communication during the CMC Review.

To access the audio and video of the webinar please click here.