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

UsernamePublicRestriction
UsernamePublicRestriction

Export ethics

This article was originally published in The Gray Sheet

Executive Summary

Regulatory Affairs Professional Society draft code of ethics could address Sec. 802(f) of the FDA Export Reform & Enhancement Act, governing export of certain unapproved products, Hogan & Hartson attorney Linda Horton opines at RAPS Asia Global Awareness conference in Universal City, Calif. June 24. Although a RAPS code is still under development, the former FDAer described Sec. 802(f) as a potential quandary for ethicists, since I don't think FDA has ever invoked" the provision...

You may also be interested in...



Reg Affairs Ethics Code To Be Unveiled At October RAPS Annual Meeting

The Regulatory Affairs Professionals Society will circulate a draft version of its evolving ethics code for member comment by the end of July

Aducanumab Review: Looking For Precedents – Long Ago And Far Afield

The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.

The Rebate Rule May Not Last, But It Changed The Pricing Debate

Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.

UsernamePublicRestriction

Register

LL1132440

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

Cancel