Closure of OGD’s Regulatory Submission Mailing Facility at
7620 Standish Place, Rockville, MD – Effective April 1, 2019
Effective April 1, 2019, FDA will no longer receive physical regulatory submissions at the 7620 Standish Place, Rockville, MD facility. Instead, submissions will be sent to the Central Document Room, 5901B Ammendale Road, Beltsville, MD 20705.
What will change?
The Rockville location will no longer receive regulatory submissions after the effective date.
All physical abbreviated new drug applications (ANDAs) will be received at 5901B Ammendale Road, Beltsville, MD 20705.
For further information, contact: Jonathan Resnick, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7997.
Please refer to the Federal Register notice published February 28, 2019 for more detail
No hay comentarios:
Publicar un comentario