OTC Zantac And Private Label Ranitidine Numerous In FDA Recall Updates
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Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 6)
A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this sixth installment of a 10-part series, experts David Elder and John McKay address communication between the front room – where investigators do the majority of their work – and the back room, used by company workers to fulfill investigator requests for documents, records and other information.
Mayzent is the first oral treatment specifically indicated for patients with secondary-progressive multiple sclerosis and while it is expected to be a blockbuster, the company tells Scrip that educational programs for physicians are a priority.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.