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Pharmaceutical Industry › Food and Drug Administration (FDA) › Risk-Based Approaches

Sheppard Mullin Richter & Hampton LLP

FDA Proposes Risk-Based and Remote Inspection Strategies in New Report

Sheppard Mullin Richter & Hampton LLP on

On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a...more

Stinson LLP

FDA Issues a Second Draft Guidance on Clinical Decision Support Software

Stinson LLP on

On September 27, 2019, FDA issued a new draft guidance on Clinical Decision Support Software, supplanting its 2017 draft guidance, Clinical and Patient Decision Support Software. ...more

Mintz - Health Care Viewpoints

Observations from FDA’s Public Workshop on Medical Device Servicing and Remanufacturing

Mintz - Health Care Viewpoints on

On December 10-11, 2018, FDA hosted a public workshop, Medical Device Servicing and Remanufacturing Activities, as part of its effort to develop a draft guidance that will distinguish servicing activities from...more

Hogan Lovells

Obtaining FDA clearance or approval of digital health products

Hogan Lovells on

Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a specific drug or biological product, as combination products requiring clearance...more

Hogan Lovells

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. ...more

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