In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to ...
Zydus Lifesciences recently received its second Form 483 reprimand from the FDA within the span of one month. In the second write-up, the regulatory agency flagged issues ranging from unqualified ...
After a site visit by FDA inspectors yielded a Form 483 for Genzyme Ireland in early 2026, the Sanofi subsidiary is facing further reprimand from the U.S. regulator. | After a site visit by FDA ...
HLB’s liver cancer drug candidate ‘Rivoceranib’ has once again failed to clear the U.S. Food and Drug Administration (FDA) hurdle. The company receive ...
A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...
Following inspections in late September, India-based generic drugmakers Lupin, Aurobindo and Cipla received Form 483s posted last week by the US Food and Drug Administration (FDA) for observations ...
The US Food and Drug Administration (FDA) has now escalated its Drug Supply Chain Security Act (DSCSA) findings at Pure Indulgence Aesthetics from a Form FDA 483 (given to the company at the close of ...
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