Industry groups and legal experts want the US Food and Drug Administration (FDA) to make significant revisions to a proposed guidance on how pharmaceutical manufacturers should address Form 483 ...

Looking to clarify its expectations for manufacturer responses following inspections, the FDA earlier this year unveiled, for the first time, draft guidance on best practices for the industry when ...

In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to ...

Drugmakers should establish “sustainable compliance practices” based on a strong quality culture, rather than simply doing the minimum required to pass inspections to avoid receiving a Form 483 or ...

The US Food and Drug Administration (FDA) has issued new draft guidance giving drug manufacturers – for the first time – formal guidance on how the agency expects firms to respond to a Form FDA 483 ...