FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees will meet jointly Oct. 20 to consider AstraZeneca's NDA 21-229 to switch its blockbuster drug Prilosec (omeprazole) OTC; the nonprescription product would be distributed by Procter & Gamble. Proposed indications the committees will review are: "To relieve heartburn, acid indigestion and sour stomach" and "To prevent heartburn, acid indigestion and sour stomach brought on by consuming foods and beverages or associated with events such as stress, hectic lifestyle, lying down or exercise." On Oct. 19, NDAC will consider the safety of phenylpropanolamine, giving attention to a CHPA-sponsored Yale study on the risk of hemorrhagic stroke and PPA (1"The Tan Sheet" May 29, p. 11)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
