Drug Approval Process – In United States of America, European Union and India: A Review

Author(s):  
Anjan K. Mahapatra ◽  
N.H. Sameeraja ◽  
P.N. Murthy
Author(s):  
Stuart O. Schweitzer ◽  
Z. John Lu

The drug approval process in any country involves a balancing of conflicting social objectives: safety and access. Faster approval leads to quicker access to potentially life-saving medicine, yet could also lead to false positives or, worse, unsafe products on the market. The United States has a widely respected but stringent and rigorous review process overseen by the Food and Drug Administration. This chapter performs an in-depth analysis of the pharmaceutical regulatory approval process in the United States. Standards, guidelines, and critical milestones for basic research, animal testing, and clinical trials in the drug R&D process are explained. It highlights major drug legislation since the beginning of the twentieth century and how this legislation has helped the FDA become the gold standard in pharmaceutical regulation worldwide. The registration pathways for generics and biosimilars are also discussed.


Author(s):  
Attarid Awadh Abdulhameed

Ukrainia Remains of huge importance to Russian Strategy because of its Strategic importance. For being a privileged Postion in new Eurasia, without its existence there would be no logical resons for eastward Expansion by European Powers.  As well as in Connection with the progress of Ukrainian is no less important for the USA (VSD, NDI, CIA, or pentagon) and the European Union with all organs, and this is announced by John Kerry. There has always ben Russian Fear and Fear of any move by NATO or USA in the area that it poses a threat to  Russians national Security and its independent role and in funence  on its forces especially the Navy Forces. There for, the Crisis manyement was not Zero sum game, there are gains and offset losses, but Russia does not accept this and want a Zero Sun game because the USA. And European exteance is a Foot hold in Regin Which Russian sees as a threat to its national security and want to monopolize control in the strategic Qirim.


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