HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

US FDA Needs ‘More Clout’ To Get Supply Chain Information, Califf Says

Executive Summary

‘It’s driving me crazy that supply chains are a trade secret,’ FDA commissioner states. Agency also needs more clout to handle accelerated approvals, he tells gathering of industry executives and government policy makers.

You may also be interested in...



US Consumer Health Industry In 2023: With Supply Chain Concerns Constant, Challenges Loom Larger

OTC drug and dietary supplement industry trade group executives discuss questions on potential market and regulatory developments affecting their members’ businesses. HBW Insight begins reporting from those talks with outlook for supply chain nd production disruptions and prevalence of COVID-19 and other widespread viruses.

To Prevent Shortages, US FDA Wants Notices From Drug Firms On Spikes In Demand

Demand-related shortages are a relatively new problem, but FDA maintains its tools can prevent or end them.

US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close

Fourteen of 15 advisory committee members said the preterm birth prevention drug should come off the market while a new study is conducted; panelists cited concerns about allowing continued marketing when efficacy has not been demonstrated, and they rejected Covis’ assertion that it would be harder to recruit a new study if Makena were pulled.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

RS153067

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