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Article Information - International Journal of ...
This article mainly focuses on the approval process of drug import and export from India. Now a day’s foreign pharmaceutical companies have a better legal foundation for releasing new drugs in India. The Indian medical regulatory system has become more complicated, and new drugs can take a year or more to be approved for marketing....
Journal of Clinical Trials and Regulatory Affairs - SciAeon
Journal of Clinical Trials and Regulatory Affairs (JCTRA) is a journal that provides a wide knowledge about the issues and challenges on analysis, design, conduct, regulation and evaluation with ethics. Clinical trials involve the efficacy of new drugs for a disease which have no proven effective therapy.
(PDF) International Journal of Drug Regulatory Affairs ...
International Journal of Drug Regulatory Affairs Open Access to Pharmaceutical and Medical Research A review on ANDA submission requirements for Generic Drugs: "Paragraph IV certification" as per ...
Regulatory Focus™ | RAPS
The US Food and Drug Administration (FDA) on Wednesday said it plans to withdraw the approval of 249 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit annual reports for the generic drugs.
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