Examples of FDA in a sentence
Failure to notify the ARRA violates the requirements of the FDA variance and federal law.
Introduction The number of laparoscopic procedures has decreased in favor of laparotomy, since the Food and Drug Administrations (FDA) decided to discourage power morcellation [1- 5] This decision was based on the occurrence of unexpected uterine (leiomyo)sarcoma during hysterectomy or myomectomy for presumed benign fibroids.
It was calculated by the FDA that this risk is as high as 1 in 498 for uterine leiomyosarcoma (ULMS).[6] However, the evidence that formed the basis for this calculation has been criticized for its weakness and potential bias.
MYDICAR is an innovative, genetically-targeted enzyme replacement therapy based on AAV1/SERCA2a that is being developed for advanced heart failure and has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA).
With the exception of the termination of the stay of approval under 21 U.S.C. § 3 5 5(j )(5)(B)(iii) as provided herein, including in Exhibit B, to the extent Supernus owns or controls any regulatory exclusivities granted by the FDA that may prevent or hinder Regulatory Approval or Marketing of the Apotex Product, Supernus hereby waives, effective as of the Apotex License Date, such exclusivities.