NIH data informs market need for a device that requires FDA clearance to achieve Medicare coverage.

The entities involved

• National Institutes of Health →

  government organization in Shah Alam, Malaysia

  • PDS Biotechnology and the National Cancer Institute entered into a collaborative R&D agreement.Sun 13:48
  • The Trump administration seeks greater control over NIH grantmaking, while Susan Collins objects to the Office of Management and Budget's involvement.Sat 04:05
• FDA →
  • Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
  • A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56
• Medicare →

  US federal health insurance

  • Advocates are calling for guardrails on AI development following a recent hack of the Medicare system.Mon 15:20
  • Leaders call for slowing AI development pace, concurrent with an AI model built by OpenAI being hacked via the Medicare portal.Mon 15:20

Related events

• A clinical study led by Dr. Swee Lay Thein is underway at the National Institutes of Health and is subject to oversight by the Food and Drug Administration.Aug 19
• A product, NitroMist®, requires FDA approval for sale, and distributor access is being established for federal supply channels.Sep 22
• NIH cuts budgets and personnel, impacting funded research leading to FDA-approved treatments.Aug 10
• NIH and HHS are mentioned together regarding funding.Jul 6
• Medicare coverage rules restrict access to FDA-approved drugs.Aug 17