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

In Brief

This article was originally published in The Tan Sheet

Executive Summary

FDA proposes amending ANDA-blocking petition reg; Sara Lee snaps up Tea Forté; testing by FDA, CDC find no bacteria in Enfamil formula powder; USP offers draft probiotics standards; more news In Brief.

You may also be interested in...



FDA Reprimands Snake Venom Seller For Pain Claims Amid Opioid Crisis

Nutra Pharma’s Nyloxin claims to relieve cancer pain and potentially help treat opioid addiction, among others, mark its products as unapproved new drugs, FDA asserts in a warning letter that reflects its homeopathic enforcement approach proposed in late 2017.  “Health fraud scams like these are inexcusable,” says FDA Commissioner Scott Gottlieb.

Gluten-Drug Rule Petitioner Claims Time Has Expired For FDA Decision

A lawsuit seeks to declare FDA’s failure to act on a 2008 citizen petition requesting a ban of wheat gluten in OTCs and Rx drugs in violation of the Administrative Procedure Act. The complaint alleges the agency’s delay is unreasonable and asks the court to order FDA to make a decision within 30 days.

Gluten-Drug Rule Petitioner Claims Time Has Expired For FDA Decision

A lawsuit seeks to declare FDA’s failure to act on a 2008 citizen petition requesting a ban of wheat gluten in OTCs and Rx drugs in violation of the Administrative Procedure Act. The complaint alleges the agency’s delay is unreasonable and asks the court to order FDA to make a decision within 30 days.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS105501

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