Pink Sheet 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

California Track-and-Trace Law Is Good Model, EMD Serono Says

This article was originally published in The Pink Sheet Daily

Executive Summary

The company has been tracking shipments of its growth hormone agent Serostim since 2002 to forestall counterfeiting and fraudulent claims and backed a full track-and-trace system during a forum sponsored by Pew Health Group. But while the system makes good business sense for a specialty firm, the acknowledgement could complicate the existing political picture for industry.

You may also be interested in...



PDUFA Negotiations: REMS Mud-Slinging, Supply Chain Compromising, GAIN Diminishing?

PhRMA and GPhA exchange unpleasantries over the legislative pay-for; FDA offers a compromise track-and-trace program that would use the industry proposal as a starting point; structure of antibiotic incentives still unresolved.

Track And Trace System Could Start With RxTEC As Foundation, FDA Says

Compromise proposal from agency would allow lot-level tracking at first, if there was a “clear path” to a more advanced system in subsequent years.

User Fee Conference Cmte. Could Be Relatively Messy After Clean Floor Votes

House and Senate avoided some contentious issues when passing their user fee bills, leaving them to an informal conference committee to work out, ideally before the end of June.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS074249

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