May 19, 2025
(U.S. Fed News)
–
WASHINGTON
,
May 19
--
Food and Drug Administration
has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; ELAHERE.
The notice was published in the
Federal Register
on
May 19
by
Grace R. Graham
, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary:
The Food and Drug Administration
(FDA or the Agency) has determined the regulatory review period for ELAHERE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the
U.S. Patent and Trademark Office
(USPTO),
Department of Commerce
, for the extension of a patent which claims that human biological product.
For more information, contact
Beverly Friedman
or
Jack Dan
,
Office of Regulatory Policy
,
Food and Drug Administration
,
10903 New Hampshire Ave
, Bldg. 51, Rm. 6200,
Silver Spring, MD
20993, 301-796-3600.
The full text of the notice can be found at: http://www.gpo.gov/fdsys/pkg/FR-2025-05-19/html/2025-08855.htm
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