New Web-based system allows OTC drug, dietary supplement manufacturers to electronically submit new product labeling, labeling updates to the Physician's Desk Reference, publisher Thomson Medical Economics says June 4. Labeling submissions are reformatted as they will appear in the PDR and posted on a secure Web site for manufacturer review, final clearance. Approved entries will be available for electronic distribution through 1www.pdr.net and on CD-ROM, with print version appearing in annual editions of the PDR for Nonprescription Drugs & Dietary Supplements. Thomson developed PDRxpress with several drug companies and says system "eliminates weeks of paper processing"...
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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.
