FDA grants manufacturer Clariant's request for a 90-day extension of public comment period for anti-dandruff ingredient safety and efficacy review to August 16. The agency "considers an extension of time for submission of data, information and general comments concerning the safety and effectiveness of piroctone olamine to be in the public interest," according to a May 19 Federal Register 1notice. Clariant had requested more time to assemble a "more comprehensive" submission (2"The Tan Sheet" May 10, 2004, In Brief)...
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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.
