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.

Insights

Further delay announced regarding the entry into application of the Clinical Trials Regulation

Registered Content

13 January 2020

The entry into application of the Clinical Trials Regulation depends on confirmation of full ..

Insights

Combination product sponsors get a new meeting option under draft FDA guidance

Registered Content

31 December 2019

The U.S. Food and Drug Administration (FDA) released a draft guidance, “Requesting Food..

News

FDA delays draft rule for QSR/ISO 13485 harmonization Medical Device Alert

25 November 2019

The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020.

News

FDA may accept DMFs for electronics and software components of drug-led combination products

01 November 2019

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could...

Analysis

International Products Law Review 2019: Issue 75

Registered Content

31 October 2019

We are excited to bring you the latest issue of our International Products Law Review with in..

News

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

24 June 2019

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid...

View more publications

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

We'd be happy to talk.

Please enter the valid data.

Your email

Please enter the valid data.

Type the text in the image here…

Please enter the valid data.

98SHc42/Fo0TuOypSOglKFwDaQYaUEgVFhKsAZCzoXY= {D4BD31A6-3DC4-40F3-A842-496ECD1CC33D} 98SHc42/Fo0TuOypSOglKFwDaQYaUEgVFhKsAZCzoXY= {B83F4964-0075-4D1D-BD72-D13588848DE8} What would you like to discuss?

;

Combination Products, FDA Jurisdictional Issues, FDA Postmarket Compliance Issues

Representative experience

Further delay announced regarding the entry into application of the Clinical Trials Regulation
Registered Content

Combination product sponsors get a new meeting option under draft FDA guidance
Registered Content

FDA delays draft rule for QSR/ISO 13485 harmonization Medical Device Alert

FDA may accept DMFs for electronics and software components of drug-led combination products

International Products Law Review 2019: Issue 75
Registered Content

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Key contacts

Related practices