Regulatory
The company plans to submit its biologic license application (BLA) to China’s National Medical Products Administration (NMPA) and other regulators worldwide.
The new approval makes it the first FDA-approved therapy in over a decade to treat HES and the third indication for the therapy overall.
A team of more than 60 scientists and bioethicists have signed a letter urging Pfizer to wait until late November before the company seeks FDA authorization of its COVID-19 vaccine candidate in an effort to ensure rigorous safety standards have been met.
On Face the Nation, Gottlieb said hospitalization rates in the United States for COVID-19 had been in a state of decline, but those numbers are now rising, which goes hand in hand with an increase in infection rates.
Pennsylvania-based Inovio said the regulatory agency has additional questions about the Phase II/III trial regarding the vaccine candidate itself, known as INO-4800, as well as the company’s Cellectra 2000 delivery device.
During his 2016 campaign, President Trump railed against high pharmaceutical prices, making promises to stand up for Americans who were being “slaughtered” on drug pricing. Now, the FDA has issued a final regulation intended to fulfill Trump’s promises.
The U.S. Food and Drug Administration (FDA) is wrapping up the month of September with a few PDUFA dates. Here’s a look.
The move was announced due to the advisor’s role in overseeing a clinical study for Moderna’s mRNA vaccine candidate.
If that guidance comes to pass, it would delay potential EUA of a vaccine until the end of 2020 or early 2021 – well after the Nov. 3 election.
Although the updated guidance has largely remained under wraps, sources who spoke to The Washington Post hinted that the new rules would make it more difficult for an EUA to be granted to a vaccine ahead of Nov. 3, the day of the U.S. elections.
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