Examples of FDCA in a sentence
In doing so, the Plaintiffs must explain in plain terms what constitutes an adulterated drug under the FDCA and whether and how they have put forward evidence that ranitidine was adulterated under that standard.
Under the Hatch-Waxman Amendments to the FDCA, a pharmaceutical company may seek expedited approval to sell a generic version of a previously approved drug and thereby avoidthe normally time-intensive and costly drug approval process.
Consecutive pagination of the OCA and the Detailed Statement does nothing to make an OCA apply to a paragraph IV notice letter’s detailed statement.Fourth, viewing the OCA and the Detailed Statement as one and the same is inconsistent with the FDCA.
Whereas fraud was not a prerequisite for assessing penalties on violators, where fraud could be proved, higher penalties would be applied.The FDCA in §304 (a) provides for the seizure of any food, drug, device or cosmetic in interstate commercethat is adulterated or misbranded.
As a result, under the FDCA, the supplements were presumptively “adulterated.” Id. at 1080-81.