Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Device clinical trial database

This article was originally published in The Gray Sheet

Executive Summary

Health Industry Manufacturers Association requests in a July 14 letter to FDA a 30-day extension of the comment period pertaining to the agency's June 22 notice seeking input on the feasibility of including medical device clinical trials in a public data bank. FDA held a public meeting July 8 to gather input on the issue (1"The Gray Sheet" July 12, p. 27). Because the agency is required by the FDA Modernization Act to submit a recommendation to Congress on the subject by Nov. 21, FDA may hesitate to extend the current Aug. 23 deadline

You may also be interested in...

Public Device Trial Database Raises Confidentiality Concerns - Industry Reps

Inclusion of device clinical trial information in a mandatory, public database could stifle technological innovation in the device industry, trade association reps cautioned at a July 8 public meeting sponsored by FDA.

Finance Watch: Silverback, Kinnate, Sigilon Launch December’s First IPOs

Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.

BioCryst’s Oral Option To Take On Injectables In HAE Prophylaxis Market

Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts