From 'Back' To 'Front': US FDA, Industry Experts Advise Device Manufacturers On Best Inspection 'War Room' Practices
This article was originally published in SRA
Ever since the first US Food and Drug Administration inspection took place decades ago, medtech manufacturers have relied on so-called "inspectional war rooms" - spaces where subject matter experts and others work to fulfill investigator needs. But such back rooms can cause headaches for medical device firms and stretch out inspections if they select unsuitable workers to staff and manage them.
You may also be interested in...
Japanese big pharma Eisai taps Celgene and Sanofi execs as its new VPs for corporate affairs and market access. And Freeline Therapeutics, developer of gene therapies for bleeding disorders, selects a former Alnylam Pharma SVP as CEO.
After two Indian vaccine makers, Serum Institute of India and Cadila Healthcare joined the fight against COVID-19, Bharat Biotech may follow suit. Others like Hilleman have decided against it for the moment while Panacea Biotech is weighing the pros and cons of developing a SARS-CoV-2 vaccine after a sour experience with H1N1.