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Form 483
Pharma
Daiichi, Eisai, Granules—Fierce Pharma Asia
Merck and Daiichi's HER3 ADC delivered a positive phase 3 result. An FDA document details shortfalls at a Granules plant in India. Plus more.
Angus Liu
Sep 20, 2024 10:16am
Granules receives Form 483 over poor document controls and more
Sep 19, 2024 10:11am
Akeso-Summit, BIOSECURE, Candid and more—Fierce Pharma Asia
Sep 13, 2024 8:53am
FDA issues Form 483s to Japanese, Indian drugmakers
Sep 10, 2024 8:50am
Sanofi, DualityBio, UCB—Fierce Pharma Asia
Aug 30, 2024 8:05am
API maker Global Calcium gets hit with FDA Form 483
Aug 29, 2024 11:52am