News
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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
