Question

The Food, Drug and Cosmetic Act

a. Is about the regulation of physical “things” most of which are put into, or onto, or used with the bodies of humans and animals.

b. Has not fundamentally changed since 1938

c. Has always allowed FDA to grant exclusivity for newly approved drugs

d. Has sole authority over product advertising

e. None of the above

Answer 1

The  Food, Drug and Cosmetic Act

a) YES, Is about the regulation of physical "things" most of which are put into , or onto, or used with bodies of humans and animals.

b) NO.There are several amendments had been done in 1951, 1962 etc.

c) NO.Several times FDCA denied FDA to grant exclusively for newly approved drugs. The FDCA requires producers of food additives to demonstrate to a reasonable certainty that no harm will result from the intended use of an additive.

d) No not the sole authority but major decisions taken by FDCA are obligatory to producer i.e. product advertizer.

Hence Answer option-(a).

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