Latest From Bowman Cox
Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.
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.
Agency requests proposals to boost surge capacity for single-use bags, tubing sets, vials, raw materials, vaccine plants.
Fewer inspections but more warning letters, import alerts and drug-shortage discretions were seen as office sought to ameliorate COVID-19 impacts.
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.
Kodak, Fujifilm and startups Civica Rx and Phlow fight with grit, vision and government support to restore US pharmaceutical manufacturing.