Controlled Correspondence / Scientific Advice with regulatory agencies – Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

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Updated on October 11, 2023

Updated on October 11, 2023

USFDA Controlled Correspondence Related to Generic Drug Development
USFDA Guidance Document – Controlled Correspondence Related to Generic Drug Development – Draft Guidance.
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions – Guidance
WHO Prequalification – Technical Advice; Advice to Manufacturers
EMA – Scientific advice and protocol assistance

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