Combination Products, FDA Jurisdictional Issues, FDA Postmarket Compliance Issues

Representative experience

We have filed numerous RFDs that successfully persuaded FDA to regulate our client’s device-drug combination product in the device center.

One of our partners was invited by the FDA to speak at an agency workshop on the regulation of innovative drug delivery systems.

Another of our partners, during his time as an FDA associate counsel, was an advisor to the chief ombudsman on combination product matters.

News

COVID-19 Report for Life Sciences and Health Care Companies (21 - 24 September 2020)

21 September 2020

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in...

News

FDA Pre-Cert update: “more work needed” to refine Streamlined Review Framework

18 September 2020

On September 14, the U.S. Food and Drug Administration (FDA) announced that it released an eight-page update on the status of the Digital Health Software Precertification (Pre-Cert) Pilot...

News

COVID-19 Report for Life Sciences and Health Care Companies (14 - 18 September 2020)

15 September 2020

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in...

News

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

11 September 2020

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or...

News

COVID-19 Report for Life Sciences and Health Care Companies (7 - 11 September 2020)

08 September 2020

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in...

News

COVID-19 Report for Life Sciences and Health Care Companies (1 - 4 September 2020)

01 September 2020

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in...

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Key contacts

Jonathan S. Kahan

Partner
Washington, D.C.

Janice M. Hogan

Partner
Philadelphia, Washington, D.C.

John J. Smith, M.D., J.D.

Partner
Washington, D.C.

Randy J. Prebula

Partner
Washington, D.C.

Jodi Scott

Partner
Denver

All related lawyers

Combination Products, FDA Jurisdictional Issues, FDA Postmarket Compliance Issues

Representative experience

COVID-19 Report for Life Sciences and Health Care Companies (21 - 24 September 2020)

FDA Pre-Cert update: “more work needed” to refine Streamlined Review Framework

COVID-19 Report for Life Sciences and Health Care Companies (14 - 18 September 2020)

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

COVID-19 Report for Life Sciences and Health Care Companies (7 - 11 September 2020)

COVID-19 Report for Life Sciences and Health Care Companies (1 - 4 September 2020)

Key contacts

Related practices

We'd be happy to talk.