Pharma Warming Up To Benefits Of Australia’s Teletrials Initiative.
Test-Pharma Warming Up To Benefits Of Australia’s Teletrials Initiative
Listen to this article
Test
Learn what's happening at the US FDA. On the go.
More from Pink Sheet
• By
Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.
• By
Approval decisions for the FDA's CNPV pilot program will be made by product center officials, but it's unclear if the responsibility lies with center directors or review office leaders.
• By
Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.
• By
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
More from Archive
• By
A new pilot aims to take Brazil closer to ‘digital transformation.’
• By
An updated guide from the Therapeutic Goods Administration proposes that sponsors of marketing applications for drugs that require companion diagnostics should provide reassurance that Australian patients will have access to at least one IVD that is adequate for companion testing.
• By
User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.