Bowman Cox
Executive Editor
Latest From Bowman Cox
Special Counsel Finds US FDA’s Dismissal Of Inspection Concerns Unreasonable
Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.
Biden Infrastructure Plan Would Boost Pandemic Preparedness, Biotech R&D, US Manufacturing
Tax hike would fund $30bn for pandemic preparations and billions more for biotech R&D and rural manufacturing jobs that are part of comprehensive infrastructure renewal proposal.
BARDA To Help Expand Manufacture Of Supplies Needed To Produce COVID-19 Vaccines
Agency requests proposals to boost surge capacity for single-use bags, tubing sets, vials, raw materials, vaccine plants.
FDA CDER Compliance Office Answered Pandemic With Fewer Inspections, Greater Discretion
Fewer inspections but more warning letters, import alerts and drug-shortage discretions were seen as office sought to ameliorate COVID-19 impacts.
US FDA Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies
Agency's Janet Woodcock and Judy McMeekin say the FDA is looking at options like livestream plant videos while preparing to address backlog after inspections can resume.
When You Can’t Win For Losing: Kodak And The Reshoring Of US Pharmaceutical Manufacturing
Kodak, Fujifilm and startups Civica Rx and Phlow fight with grit, vision and government support to restore US pharmaceutical manufacturing.