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Clinical trials: new FDANIH draft guidance would permit broader patient waiver

Sidley Austin LLP
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USA
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September 26 2011

A September 19 draft guidance jointly issued by Food and Drug Administration (FDA) and National Institutes of Health’s Office for Human Research Protections (OHRP) would allow sponsors of clinical trials to require humans subjects to waive certain legal rights, including those related to biospecimens collected for research

FDA draft guidance on mobile apps signals increased regulatory oversight

Sidley Austin LLP
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USA
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July 27 2011

On July 20, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance identifying the mobile device applications“apps”the agency plans to regulate as medical devices

FDA shift on diagnostics lays groundwork for regulation of lab-developed tests global life sciences - U.S. FDA update

Sidley Austin LLP
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USA
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July 15 2011

On July 12, 2011, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) announced plans to down-classify and exempt from Section 510(k) premarket notification a range of in vitro diagnostic and radiology device types

New FDA draft guidance holds IVD manufacturers responsible for clinical use of ROUIUO products

Sidley Austin LLP
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USA
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June 16 2011

In a new proposed guidance, FDA has signaled its intention to shift responsibility for the use of certain medical devices from customers to manufacturers, based on an expansive and legally questionable presumption of “intent.”

FDA announcement on ReGen signals aggressive new posture on 510(k) “rescission”

Sidley Austin LLP
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USA
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October 18 2010

On October 14, 2010, the Food and Drug Administration (FDA) announced that the Menaflex Collagen Scaffold, an orthopedic device cleared for marketing in 2008, "should not have been cleared for marketing in the United States" and that its clearance would be "rescinded."

U.S. Food and Drug Administration and European Medicines Agency enter into new good clinical practices collaboration

Sidley Austin LLP
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European Union, USA
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August 5 2009

On August 3, 2009, the U.S. Food and Drug Administration (FDA) announced a collaborative agreement with the European Medicines Agency (EMEA) for a Good Clinical Practices (GCP) Initiative

Early release of AAHRPP proposed revised accreditation standards

Sidley Austin LLP
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USA
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June 2 2009

On June 1, 2009, the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) announced the release of its proposed revised accreditation standards

Search results

Clinical trials: new FDANIH draft guidance would permit broader patient waiver

FDA draft guidance on mobile apps signals increased regulatory oversight

FDA shift on diagnostics lays groundwork for regulation of lab-developed tests global life sciences - U.S. FDA update

New FDA draft guidance holds IVD manufacturers responsible for clinical use of ROUIUO products

FDA announcement on ReGen signals aggressive new posture on 510(k) “rescission”

U.S. Food and Drug Administration and European Medicines Agency enter into new good clinical practices collaboration

Early release of AAHRPP proposed revised accreditation standards

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