Examples of FDA in a sentence
The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA.
The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
Other than as disclosed on Schedule 3.1(hh), the Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
In addition to Neuronetics, Neuronetics may share the Limited Data Set or outputs derived from the Limited Data Set with the following types of third party entities: • regulatory agencies (e.g., FDA, U.S. Department of Defense, U.S. Department of Veterans Affairs); • clinicians and researchers; • Neuronetics customers; and • contract research organizations.
This DUA allows Neuronetics to use Customer’s information to create a Limited Data Set and use and disclose the Limited Data Set for research, public health, or health care operations, including inclusion in regulatory filings (e.g., FDA submissions), data analytics supporting research initiatives or healthcare operations, and internally by Neuronetics to perform product evaluation and improvements.