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Sep 14, 20212 min read

USFDA’s Study Data Technical Conformance Guide & Technical Specifications Doc Update -USA

Study Data Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit standardized...

Sep 8, 20211 min read

USFDA's Novel Excipient Review Pilot Program

The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which...

May 8, 20211 min read

Expectations & Challenges in Conducting Virtual Inspections- USFDA and EMA

Regulators from 11 agencies, representing the US, the UK, Spain, Germany, and Russia, discussed their views on these challenges and...