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FDA Advisory Committee Review of 2021

Eye on FDA

But before heading into 2022, it is perhaps time to take stock of AdComms and what they did or did not do during 2021. First and foremost is that as noted earlier this year (See August 5, 2021 FDA Adcomms – Is FDA Getting Less Advice? ), there were fewer 2021 meetings held to consider new drug applications than in years gone by.

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AdComms – Is FDA Getting Less Advice?

Eye on FDA

At the same time, looking to 2018 when there were 29 meetings to consider new drugs, the number appears to be falling each year, with only 6 that occurred during the first half of 2021. That said, BT would be a lagging indicator since it can be granted so early in the development process. Fewer meetings – more approvals.

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Twenty Women Leaders In Healthcare Industry

PharmaShots

Designation: Chief Commercial Officer (CCO) and President Award & Nominations: She has her mention in Fortune’s “Top 50 Most Powerful Women” in 2020, 2021, and 2022 ranking 16th, 11th, and 13th respectively. Other Affiliations: She is a fellow of the Royal Society (May 2021) associated with Merck.

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COVID-19 has propelled the regulatory industry years ahead

pharmaphorum

The development of COVID-19 vaccines required levels of cooperation and pioneering science comparable to the Apollo space programme. Within 12 months of the outbreak, vaccines were being deployed to prevent severe infections, hospitalisation, and death. billion people have been fully vaccinated. Last accessed: October 2021.

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2022 in review: Drug development milestones for tropical diseases

Pharmaceutical Technology

Novel therapeutics and vaccines for malaria. This year saw great progress towards making new therapeutics for malaria available sooner rather than later, says Karen Barnes, PhD, professor at the University of Cape Town’s Division of Clinical Pharmacology. Pyramax was codeveloped by MMV and the South Korean company Shin Poong.