Pfizer Rid Mousse Pediculicide Approved Under "NDA Deviation"
FDA approved an "NDA Deviation" (21-043) for Pfizer's Maximum Strength Rid Mousse aerosolized foam lice treatment March 7. It is one of the first "NDA Deviations" to get the go-ahead from the agency; such an application is for a product that is comparable to products in a monograph but deviates in a significant way.
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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.’
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The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.
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.
US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease