2023 2024 EduVark > Education Discussion > Entrance Exams


  #2  
April 17th, 2015, 09:51 AM
Super Moderator
 
Join Date: Mar 2012
Re: FDA Food Drug Cosmetic

United States Federal Food, Drug, and Cosmetic Act (FFDCA) is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.

FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.


Contents of FFDCA:

I. Short Title

II. Definitions
201(f) is the definition for a food, which explicitly includes chewing gum
201(g) is the definition for a drug
201(h) is the definition for a medical device
201(s) is the definition of a food additive
201(ff) is the definition of a dietary supplement

III. Prohibited Acts and Penalties
This section contains both civil law and criminal law clauses. Most violations under the act are civil, though repeated, intentional, and fraudulent violations are covered as criminal law. All violations of the FD&C Act require interstate commerce because of the commerce clause, but this is often interpreted broadly and few products other than raw produce are considered outside of the scope of the act.
Notably, the FD&C Act uses strict liability due to the Dotterweich[6] and Park[7] Supreme Court cases. It is one of a very small number of criminal statutes that does.

IV. Food
There is a distinction in food adulteration between those that are added and those that are naturally present. Substances that are added are held to a stricter "may render (it) injurious to health" standard, whereas substances that are naturally present need only be at a level that "does not ordinarily render it injurious to health"[8]

V. Drugs and Devices
505 is the description of the drug approval process
510(k) is the section that allows for clearance of class II medical devices
515 is the description of the (class III) device approval process
VI. Cosmetics

VII. General Authority
704 allow inspections of regulated entities. Inspection results are reported on Form 483.

VIII. Imports and Exports

IX. Tobacco Products

X. Miscellaneous


Quick Reply
Your Username: Click here to log in

Message:
Options



All times are GMT +5. The time now is 09:36 PM.


Powered by vBulletin® Version 3.8.11
Copyright ©2000 - 2024, vBulletin Solutions Inc.
Content Relevant URLs by vBSEO 3.6.0

1 2 3 4 5 6 7 8