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# Comments on FDA Bridging Draft Guidance
- URL: https://www.fdaweb.com/comments-on-fda-bridging-draft-guidance/
- Published: 2020-04-22T12:00:00.000Z
- Updated: 2026-09-14T16:12:12.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5146629

Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes that additional clarify and increased consistency from FDA on the bridging of information approaches for drug-device and biologic-device single entity and co-packaged combination products promote efficiency in the development process that can lead to timely access to new and improved products for patients. The association’s [comment](https://www.regulations.gov/document?D=FDA-2019-D-5585-0014&ref=fdaweb.com) on an FDA draft bridging guidance also says sponsors would benefit from an FDA-hosted Webinar focused on the draft guidance before it is finalized. “Such a Webinar or public meeting could clarify the specifics of each case study in the draft guidance and contribute to a greater shared understanding of FDA’s recommendations for bridging information in combination product development efforts,” the letter says. PhRMA also provides specific text comments.

The Association for Accessible Medicines [recommends](https://www.regulations.gov/document?D=FDA-2019-D-5585-0013&ref=fdaweb.com) that additional clarify be added throughout the guidance further detailing the information linking the content and applicability to 505(j) and 351(k) applications. It also provides technical line-by-line comments.

A Biocon comment [letter](https://www.regulations.gov/document?D=FDA-2019-D-5585-0012&ref=fdaweb.com) contains specific technical comments.