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Latest From Bowman Cox
FDA Gives Firms One Month To Fix Listings Before Barring Drugs From US Market
Tens of thousands of listed drugs could be barred if manufacturers do not update their records.
ICH Hires Trainers As Emerging Authorities Strive To Harmonize
ICH prepares to lift veil on global regulatory harmonization progress as it hires trainers to speed up the process.
FDA's Withdrawn Reg On Data Fraud Hangs Over Zolgensma Incident
Democratic senators push data-challenged gene therapy into maw of drug pricing debate as they press acting commissioner Sharpless to bring the hammer down on Novartis, but also question US FDA's decision to withdraw the proposed rule last year.
Key Senator Hinges Support For Cheap Drug Imports On Surprise Inspections
More unannounced inspections abroad would warm Senate Finance Committee chairman to President Trump's drug importation plan.
Pfizer/Mylan: Pending Clash Of Quality Systems Could Determine Fate Of New Firm
After years of Mylan’s “one quality standard,” the merger with Pfizer Upjohn brings another. Which will prevail? Which should prevail?
US FDA Drops Plan To Simplify Pharmaceutical Plant Reporting
Industry complained draft guidance would have made manufacturing establishment information harder to report, not easier.