The Company's submission was made in response to FDA's clarification to allograft putty providers, including Wright, that such products are regulated under the federal Food, Drug, and Cosmetic Act
, and require premarket review submissions.
The Commissioner's Special Citation is granted solely at the Commissioner's discretion for contributions and accomplishments the Commissioner deems appropriate to recognize for their contribution to the mission of the Food and Drug Administration: To protect the public health, as directed by the Federal Food, Drug, and Cosmetic Act
, and to administer the statutory framework of this law by providing new and better products.
The Company began the 510(k) premarket notification process in March of 2002, following FDA's clarification to all allograft putty providers that such products are considered medical devices and are therefore regulated under the federal Food, Drug, and Cosmetic Act
The company intends to file a new drug application (NDA) under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act
The NDA for ZEGERID Capsules was submitted under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act
which allows an alternative path for FDA approval of new or improved formulations of previously approved products.
Following final analysis of the trial data and completion of the stability programs, the company plans to file a new drug application (NDA) under Section 505(b)(2) of the Federal, Food, Drug, and Cosmetic Act
with the U.
LAST OCTOBER, the Food and Drug Administration sent John King a stern letter warning him that he had committed "serious violations of the Food, Drug, and Cosmetic Act
," that to continue to market his product he would need to file a "New Drug Application," and that failure to comply might result in "seizure of violative products.
The actual language of US Federal Drug Administration Judge Davidson's ruling is "Enrofloxacin found not shown to be safe under the conditions of use upon the basis of which the application was approved as required under [section] 512(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act
(the Act) [21 U.
In conclusion, good science and the law (Federal Food, Drug, and Cosmetic Act
1997; Federal Inssecticide, Fungicide and Rodenticide Act 1972; Food Quality protections Act of 1996) require the U.
The Food, Drug, and Cosmetic Act
requires that cosmetics and their individual ingredients must be safe and that labeling must be truthful and not misleading.
This portion of the Food, Drug, and Cosmetic Act
, known as the Delaney clause, dates back to 1958, when technologies for detecting carcinogens picked up only gross contamination.
In 1938 the Federal Food, Drug, and Cosmetic Act
enlarged the Food and Drug Administration's regulatory powers, authorizing the government agency to hold medical devices to some of the same standards as drugs.