Caraco settles with US FDA on GMP violations
This article was originally published in Scrip
Executive Summary
Caraco Pharmaceutical Laboratories has entered into a consent agreement with the US FDA that bars the company from re-starting generic drug manufacturing operations at its facilities in the Detroit, Michigan, area until they comply with good manufacturing practices (GMPs).
You may also be interested in...
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.
RWE: Non-Interventional Studies Must Be Able To Distinguish A True Treatment Effect, US FDA Says
Agency describes a host of issues sponsors should consider and address before pursuing observational or case-control studies to support regulatory decision-making on drug efficacy or safety; new draft guidance was issued under the FDA’s Real-World Evidence program.
Eye On ODAC: Former Members, FDA’s Pazdur Talk Pre-Meeting Mindsets, Impact Of Sponsor’s Experts
Oncologic Drugs Advisory Committee reps and the Oncology Center of Excellence director go behind the scenes to discuss FDA interactions with panelists, how opinions can change during a meeting, and why the voting question is important.