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
UsernamePublicRestriction

FDA Commissioner's India Trip Underscores Quality Theme and Regulatory Leverage

This article was originally published in RPM Report

Executive Summary

Hamburg goes to engage and educate but also to deliver a message to Indian manufacturers: FDA has more funding, human resources, and authorities than it has ever had before to regulate firms outside of the US.

You may also be interested in...



Culture Clash: FDA Tries to Re-Educate Indian Firms on Processes and Accurate Reporting

FDA has essentially shut down Ranbaxy’s three-year-old facility at Mohali as a source for products for the US market. But Ranbaxy is not alone among Indian firms in its quality product disputes with the agency. There is a significant uptick in activity by FDA in the region in what appears to be a period of intense culturization for the Indian firms into the ways FDA enforces cGMPs and handles on-site inspections.

FDA-CMS Parallel Review Pilot Will Be Extended; Drugs Not The Focus

CMS remains open to the idea of using parallel review (or, less formal parallel advice) for prescription drugs, but the current and future focus of the pilot program is likely to stay on devices and diagnostics.

Personalized Medicine Meets Payment Policy: MEDCAC Has “Low Confidence” In Most Cancer Tests

Genomic screening of tumor types may be the cutting edge in cancer treatment and a central component of the President’s vision for personalized medicine. But how much evidence is necessary to make insurance coverage for testing routine?

Topics

Related Companies

UsernamePublicRestriction

Register

ID1135947

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