"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or are dosed with liquids may be more appropriately considered to be chewable or oral tablets," FDA says in a draft guidance on orally disintegrating tablets scheduled for publication in the Federal Register April 9.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.’
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.
