P&G expects final approval of OTC Prilosec (omeprazole) for prevention of frequent heartburn early in the first quarter of 2003, firm says following Aug. 8 FDA letter deeming drug "approvable" pending label modifications and a label comprehension study. Company says FDA's correspondence gives it a "much better understanding of what is needed in a label comprehension study." In June, agency advisory committee members voted 16-2 in favor of switching the proton pump inhibitor OTC, but recommended significant labeling changes and an additional comprehension study (1"The Tan Sheet" June 24, 2002, p. 3). FDA's letter came three days after P&G told analysts during its Aug. 5 fiscal year-end earnings call that it hoped for final OTC approval before 2003 (2"The Tan Sheet" Aug. 12, 2002, p. 7)...
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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.’
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.
