How data integrity related problems should be addressed in Pharmaceutical and Biopharmaceutical Industry?
Drug Regulatory Body encourages to demonstrate that organization have effectively remediated problems by investigating to determine the problem’s scope and root causes,... Read More
Take a self competency test in authorized generics
In the U.S., prescription drugs approved by the federal Food and Drug Administration (FDA) are granted a specified period of market exclusivity,... Read More
GSK’s Shingrix received chinese approval for shingles vaccine
Posted on24 May 2019
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GaxoSmithKline (GSK) has secured approval from China’s National Medical Products Administration (NMPA) for Shingrix vaccine to prevent shingles (herpes zoster) in adults... Read More
What is an “audit trail”?
Audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation,... Read More
What is difference between New Drug Application and Marketing Authorization Application?
Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval,... Read More