The US Food and Drug Administration (FDA) has notified sponsors of new and generic drug applications that in vitro bioequivalence (BE) studies conducted by Raptim Research, an Indian contract research ...

BETHESDA, MD – Data integrity issues were the primary reason for the US Food and Drug Administration’s (FDA) delay in approving abbreviated new drug applications (ANDAs) past their review goal date, ...

The U.S. Food and Drug Administration has flagged data integrity, manufacturing and maintenance lapses at one of Dabur India's plants following an inspection earlier this year, according to an ...

The US Food and Drug Administration has placed Dabur India's factory on an import alert. This action follows an inspection ...