Examples of Health Care Regulatory Laws in a sentence
The Company has not received notice of adverse finding, warning letter, or clinical hold notice from an IRB, IEC, FDA, EMEA, or similar Governmental Entity, or any untitled letter or other correspondence or notice from the FDA or any other Governmental Entity or any institutional or ethical review board alleging or asserting noncompliance with any Health Care Regulatory Laws applicable in any jurisdiction.
Except as set forth in Schedule 2.27(a) of the Company Schedules, neither the Company, any Subsidiary, or any Affiliate thereof has received any written or oral notice or complaint from a Governmental Entity or any other Person, that allege that the Company or such Subsidiary is not in compliance with any such Health Care Regulatory Laws and that have not been addressed to the satisfaction of such Governmental Entity or complainant.
Except as set forth in Schedule 2.27(a) of the Company Schedules, the Company and each Subsidiary is operating and has operated in material compliance with the Health Care Regulatory Laws.
Neither the Company nor any Subsidiary has been the subject of or received, or has knowledge of any pending or, to the Company’s knowledge, threatened: (i) compliance, disciplinary or enforcement action from any Governmental Entity; (ii) any written notice of noncompliance with or alleged violation of any Health Care Regulatory Laws; or (iii) material finding from an inspection by a Governmental Entity.
Health Care Regulatory Laws In the United States, the research, manufacturing, distribution, marketing, sale and promotion of medical devices are subject to numerous regulations by various federal, state and local governmental authorities in addition to the FDA.