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FDA Offers Guidance on Companion Diagnostics for Groups or Classes of Cancer Drugs

USA - December 18 2018 In the 7 December 2018 Federal Register, the US Food and Drug Administration (FDA) announced the availability of its new draft guidance document...

Neil O'Flaherty.

FDA Engages in Patient Engagement - How Will It Affect Medical Device Regulation?

USA - November 28 2018 The Patient Engagement Advisory Committee (PEAC) to the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH or...

Neil O'Flaherty.

FDA Takes Aim at Unapproved Human Cellular Therapy Product and its Company

USA - November 19 2018 The U.S. Food and Drug Administration (FDA) sent an 31 October 2018 Warning Letter to San Diego-based StemGenex Biologic Laboratories LLC (StemGenex)...

Neil O'Flaherty.

Another Step Forward - FDA Issues Two Final Guidance Documents on Communicating Medical Product Information

USA - June 21 2018 On 12 June 2018, the Food and Drug Administration (FDA) issued two final guidance documents providing feedback on acceptable means for drug and device...

Neil O'Flaherty.

FDA And 3D Printing What Will The Regulatory Regime Become?

USA - December 18 2017 The US Food and Drug Administration (FDA) already has had its regulatory eye on 3D printing for some time. The Agency already has evaluated and...

Neil O'Flaherty.