
FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.

Jill Wechsler is BioPharm International's Washington Editor, jillwechsler7@gmail.com.

FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.

Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.

Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.

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.

Problems in assuring reliable drug quality and supply dampens progress in bringing lifesaving therapies to market.

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