#fda #oncology | Alison Bateman-House

I'm excited to be part of #FDA #Oncology Center of Excellence's webinar on Project Facilitate today! Project Facilitate is OCE's fantastic service for those who need some help with an Expanded Access...

Senate appears ready to slow down the push to create experimental treatment centers

Legislation to make New Hampshire a mecca for creating experimental treatment centers has run into bipartisan resistance from state senators who have concluded that the cutting-edge issue needs...

Genetic Therapies for Rare Diseases: Developing Ethical Regulatory Policies : The Hastings Center...

To boost innovation in gene-based therapies, it is important to address not only scientific, manufacturing, and commercial challenges, but also ethical and regulatory issues.

Rare disease advocates fume over FDA's mixed signals

Families facing rare diseases feel whiplash over shifting and contradictory decisions by the FDA.

Wyoming stem cell bill is latest risky, anti-FDA state legislation - The Niche

Stem cell biologist discusses a new Wyoming stem cell bill that is latest anti-FDA state legislation that poses risks to consumers.

Pharma CEOs should demand Prasad’s departure

It is past time for life sciences industry leaders to publicly demand Vinay Prasad’s firing.If FDA Commissioner Marty Makary is unwilling to part wi...

Prasad overruled vaccine review team, office director on Moderna flu shot

FDA's Vinay Prasad overrules staff to reject Moderna flu vaccine review, contradicting vaccine team's recommendation. Decision sparked controversy over trial requirements.

CMS’ new MAHA ELEVATE innovation model has a fundamental flaw

CMS’ new MAHA ELEVATE innovation model has a fundamental flaw, The Workup columnist Vishal Khetpal writes.

Controversial CDC hep B vaccine study in Guinea-Bissau may be canceled

“Never Seeing a Doctor in the U.S. Again”

As health-care costs rise, videos of Americans going overseas for medical testing and procedures have started trending online. What’s the catch?

COMMENTARY: When confusion replaces clarity about vaccines, children pay the price

Is 'shared decision-making' being hijacked by U.S. health officials to sow doubt about vaccines?

Experts worry that health officials' use of 'shared decision-making' in new vaccine guidance distorts the concept's meaning and disregards the importance of evidence.