Jill Wechsler is BioPharm International's Washington Editor, jillwechsler7@gmail.com.
FDA Highlights Value and Challenges of Advanced Drug Manufacturing
FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.
COVID-19 Vaccine Distribution Raises Multiple Challenges
Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.
Surge in Cellular and Gene Therapies Challenges FDA
Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.
FDA Caught in Political Crossfire
FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients.
Quality Issues Offset Biomedical Advances
Problems in assuring reliable drug quality and supply dampens progress in bringing lifesaving therapies to market.