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Samples in periodicals archive:
Under the Federal Food, Drug and Cosmetic Act (FD&C Act) of 1938, it is a crime to market unsafe cosmetic products.
``The court finds that tobacco products fit within the Food, Drug and Cosmetic Act's definition of `drug' and `device,' '' Osteen wrote.
Hana has submitted an NDA for Zensana under Section 505 (b)(2) of the Food, Drug and Cosmetic Act to seek approval for the prevention of nausea and vomiting as a result of chemotherapy, radiation, and surgery.
In addition, DUSA believes that certain actions of The Cosmetic Pharmacy go beyond the activities which are permitted under the Food, Drug and Cosmetic Act, and as a result, it has advised the U.
The injunction had originally been ordered pending final resolution of CollaGenex's challenge to the FDA's decision to classify Periostat(R) as an antibiotic, thereby denying CollaGenex the patent and exclusivity protection otherwise available under the Hatch Waxman amendments to the Food, Drug and Cosmetic Act.
CollaGenex also continues to challenge in the United States District Court for the District of Columbia the decision of the Food and Drug Administration ("FDA") to classify Periostat(R) as an antibiotic, and has sought to compel the FDA to accord CollaGenex patent and exclusivity protection under the Hatch Waxman amendments to the Food, Drug and Cosmetic Act.
Surgin moved to dismiss the complaint on the basis that whether a product has 510(k) clearance or needs a second 510(k) clearance are questions for the FDA to decide under the Federal Food, Drug and Cosmetic Act.
Because no therapeutic health claims have been made by the plaintiffs, "time after time, for more than 80 years, the FDA and its predecessors have informed Congress that cigarettes are beyond the scope of the Food, Drug and Cosmetic Act," Parrish said.