"Tablets that take longer than 30 seconds to disintegrate or are dosed with liquids may be more appropriately considered to be chewable or oral tablets," FDA says in a draft guidance on orally disintegrating tablets scheduled for publication in the Federal Register April 9. Additional parameters for consideration include tablet size, weight and component solubility, the agency adds. Because performance characteristics distinguish these products as separate dosage forms, matching the characteristics is an important requirement for ODT labeling, FDA notes. A wide variation in product characteristics in the first disintegrating tablets to reach the market prompted the agency to develop guidance for the category. Excedrin QuickTabs and Claritin Redi-Tabs are among the offerings in the OTC market...
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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.
