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USFDA makes 22 observations post inspection of Lupin's Mandideep facilities
Drug major Lupin Wednesday said the US health regulator has made a total of 22 observations after inspection of its facilities loacated at Mandideep in Madhya Pradesh.
USFDA recommends regulatory action after Jubilant Life's Roorkee plant inspection
The US health regulator has recommended a regulatory or administrative action after the inspection of Roorkee manufacturing facility of drug firm Jubilant Life Sciences, according to a regulatory filing.
Real World Evidence
FDA issues framework for Real-World Evidence Program
Advancing Toward the Goal of Global Approval for Generic Drugs
FDA Proposes Critical First Steps to Harmonize the Global Scientific and Technical Standards for Generic Drugs
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