Pink Sheet 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

Califf: More Learning Necessary During Generic Drug Lifecycle

Executive Summary

The US FDA commissioner called for enhancements to postmarketing data collection and analysis for generic drugs.

You may also be interested in...



Good Clinical Practice Inspections Take On Narrower Focus During Pandemic, US FDA Says

Technological and logistical challenges have forced agency staff to triage document and interview requests to focus on the most important issues when conducting remote regulatory assessments and in-person inspections, an FDA official told a conference of international regulators.

Biden Requests US FDA Budget Surge: Pandemic Preparedness Money Would Increase Funding 36%

President Biden’s budget request would add $1.63bn in mandatory funding to the FDA budget in FY 2023.

US FDA Investigating Auto-Injector Problems With Copaxone Generics

Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS146071

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