CDER Small Business Webinar on Guidance for Industry: ANDA Submissions – Refuse-to-receive Standards - November 18, 2013

The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.

These focused webinars support the Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business with information relating to the development and regulation of human drug products.
On Monday November 18, 2013, the CDER Small Business Assistance Program presented a webinar entitled the Guidance for Industry: ANDA Submissions – Refuse-to-Receive Standards.
The webinar objectives:
  • Clarify implementation dates (what is current policy and when future policy will be implemented)
  • Highlight specific points/topics covered by the draft RTR guidance
  • Clarify points in the draft guidance that have raised concerns/questions via Docket comments and feedback from a similar presentation delivered at the 2013 Generic Pharmaceutical Association Fall Technical Conference (Oct. 28-30, 2013)
  • Answer further questions provoked by the draft guidance
Johnny Young, Office of Generic Drugs (OGD)/CDER/FDA
Johnny Young has served as a Regulatory Filing Reviewer in OGD/Division of Labeling and Program Support since May 2007.  Prior to that, he was in retail pharmacy practice for 18 years.  Mr. Young has a BS in Pharmacy from the University of MD; a BA in English Literature from the University of MD, Baltimore County; and a Liberal Arts Masters from St. John’s College in Annapolis.

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