2007, IT, Medical and Vaccination

Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law Blog

FEBRUARY 4, 2025

As our readers may already know, FDA maintained three PRV programs to incentivize the development of therapies for underfunded diseases: the RPD PRV program, which sunset last month, the Medical Countermeasures (MCM) PRV Program, which sunset in October 2023, and the Tropical Disease PRV Program.

IT Vaccination Manufacturing Medical

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Koblitz & Deborah L. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.”

Manufacturing

Manufacturing Consulting Healthcare Professional Vaccination

What RFK Jr. Isn’t Talking About: How To Make Vaccines Safer

Physician's Weekly

JUNE 26, 2025

Within an hour of receiving a covid vaccination in November 2020, Utah preschool teacher Brianne Dressen felt pins and needles through her arms and legs. In the medical odyssey that followed, she suffered double vision, chronic nausea, brain fog, and profound weakness. system for monitoring the rare ill effects of vaccines.

Vaccination

Vaccination Patient-Centered Government IT

Primary Care Digest

Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA-Approved Labeling: Is Enough Enough?

What RFK Jr. Isn’t Talking About: How To Make Vaccines Safer

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