US COVID-19 Vaccine Booster Plan Also Boosts Pressure On FDA
The plan’s White House announcement was described as a transparency move, but meeting its 20 September target start date requires both the FDA and ACIP to act quickly on boosters.
You may also be interested in...
As decisions on additional boosters and childhood inoculations loom, CBER Director Peter Marks is still heading the vaccines division on an acting basis since the departures of Marion Gruber and Philip Krause last year. Who might succeed them?
Three new guidances were announced the morning of President Biden’s State of the Union address, but experts said the move did not equate with past White House pressure on agency decisions.
Former Official Petitions US FDA To Stop Reviewing Russian Firms' Applications Amid Ukraine Invasion
Request from Tim Coté, former Office of Orphan Products Development director, could drag agency back into a political arena it's been trying to avoid. Coté, now consulting through Only Orphans Coté, filed a citizen petition asking agency to “completely freeze all administrative actions on any regulatory requests,” from drug and device companies headquartered in Russia or with majority Russian ownership.