PDUFA VI launches: Not Pluto flyby, but has potential

Jul 16 2015

• By Donna Young

Listen to this article

While the launch of the sixth round of the Prescription Drug User Fee Act (PDUFA), which officially got underway on 15 July, was far less dramatic than the Pluto flyby, the process ahead for the FDA and the biopharmaceutical industry, nonetheless, has the potential to boost scientific innovation and speed new therapies and cures to the market – helping to make life better for those down on Earth, declared Dr Stephen Ostroff, acting commissioner of the FDA.

While the launch of the sixth round of the Prescription Drug User Fee Act (PDUFA), which officially got underway on 15 July, was far less dramatic than the Pluto flyby, the process ahead for the FDA and the biopharmaceutical industry, nonetheless, has the potential to boost scientific innovation and speed new therapies and cures to the market – helping to make life better for those down on Earth, declared Dr Stephen Ostroff, acting commissioner of the FDA.

Indeed, since its creation by Congress in 1992, PDUFA has been a "great facilitator in the ability to bring products...

More from Anticancer

Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC
Dec 05 2025
• By Xu Hu
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]
Nov 12 2025
Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC
Nov 12 2025
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
Allarity Hopes To Breathe New Life Into Ixempra In Breast Cancer
Sep 24 2025
The US precision medicine company hopes its drug response predictor technology will enhance responses to the chemotherapy Ixempra on the basis of promising data from a handful of breast cancer patients in a Phase II trial, marking a positive turn in its journey to date.

More from Therapeutic Category

Scrip Data Article Without An Author
Nov 19 2025
"Neque porro quisquam est qui dolorem ipsum quia dolor sit amet, consectetur, adipisci velit..."
Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]
Nov 12 2025
Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC
Nov 12 2025
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.