Examples of Food and Drug Administration in a sentence
The vaccine must be a COVID-19 vaccine that is authorized or approved for use by the U.S. Food and Drug Administration.
Neither the Company nor any of its subsidiaries has received any unresolved FDA Form 483, notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration (“FDA”), or any other federal, state, local, or foreign governmental or regulatory authority, alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) or comparable applicable law.
In this regard, Xxxxx agrees to notify ZEISS within 10 days of the occurrence of any event identified in the Devices Act imposing a reporting obligation on Buyer and/or ZEISS (except for events representing an imminent hazard that require notification to the United States Food and Drug Administration ("FDA") within 72 hours, in which case, such notice will be delivered to ZEISS immediately.
In the event of an inquiry or an inspection of the Facilities by a representative of the U.S. Food and Drug Administration or any other federal, state, or local regulatory agency, Manufacturer shall immediately notify Company if the inquiry or inspection concerns or involves the provision of the services described herein with respect to Products or Ingredients or Packaging Materials to be used therein.
GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the U.S. Food and Drug Administration as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time.