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.’
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The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
