Drug-Administration Controversy

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The Food, Drug and Cosmetic Act of United States (abbreviated as FDCA) is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) of the country to oversee the safety of food, drugs, and cosmetics. As per the act:
A drug is adulterated if the methods used in or the facilities or controls used for its manufacturing, processing, packing or holding do not conform to or are not operated or administered in conformity with current Good Manufacturing Practice (cGMP) regulations.
This assures that a drug meets the requirements as to safety and has the identity and strength, and meets the quality and purity characteristics, which the drug purports or is represented to
…show more content…
Code § 271(e) which is known as the Infringement of Patent Act of United States:
It shall be an act of infringement to submit -
(A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent,
(B) an application under section 512 of such Act or under the Act of March 4, 1913 (21 U.S.C. 151–158) for a drug or veterinary biological product which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques and which is claimed in a patent or the use of which is claimed in a patent.
As per the Israeli generic drugs company - Teva Pharmaceuticals, the Allegan, Mich. based Perrigo’s planned generic albuterol sulfate aerosol inhaler designed with drug development services company Catalent Pharma Solutions LLC infringed with four patents licensed by Teva for Proair® HFA. U.S. Patent Numbers: 7,105,152; 7,566,445; 6,446,627 and 8,132,712. Each patent-in-suit is valid which had been granted to Teva are set to expire variously between June 2017 and September 2023 and still Perrigo filed an abbreviated new drug application with the

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