FDA Law

MAY 15, 2025

He spoke with obvious enthusiasm about the recently announced pilot AI-assisted review and its potential to shave weeks off approval timelines, as he described hearing from one reviewer in the pilot project who said the pilot AI tool completed three days work in gleaning salient facts from medical literature in six minutes.

Manufacturing 59

Manufacturing Illness Vaccination IT 59

FDA Law

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. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

FDA Law

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. We will continue to monitor these developments as they come.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

Medical Xpress

DECEMBER 23, 2022

If B cells are the munitions factories of the immune system, manufacturing antibodies to neutralize harmful pathogens, then the tiny biological structures known as germinal centers are its weapons-development facilities.

Manufacturing 105

Manufacturing Vaccination IT Medical 105

Medical Xpress

JANUARY 24, 2025

A West Virginia University legal scholar says current laws may be giving manufacturers of biologic drugs, like antibodies and flu vaccines, too much in the way of legal protections before copycat versions can be sold when compared with traditional small-molecule drugs, including antibiotics and steroids.

Medical 45

Medical Manufacturing Vaccination 45

FDA Law

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 52

IT Vaccination Manufacturing Medical 52

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

By Wes Stubblefield, MD, MPH, FAAP ADPH Medical Officer H5N1 influenza, or “bird flu,” is a type of influenza that was first discovered in the 1950s. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

FDA Law

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

Doctors for America

MAY 15, 2025

It is incredibly alarming that in his first time testifying before the HELP Committee since taking the oath of office, Secretary Kennedy chose to defend the dismantling of our nation’s public health agencies and engage in false rhetoric around vaccine safety and efficacy.

Medical Student 96

Medical Student Medical Advice Vaccination Education 96

Tiny Physician

OCTOBER 17, 2021

On the brighter side, daily case count drastically decreased and vaccination drive is happening at top speed. Almost 1 billion doses of vaccine have been administered so far and the situation is currently under control. All the sectors have resumed their work like the pre-covid times and in Kerala also, the situation is the same.

Vaccination 52

Vaccination Government Physicals IT 52

GeriPal

OCTOBER 31, 2024

Our conversation covers: The current state of COVID Evidence for COVID boosters, who should get them, and preferences between Novavax and mRNA vaccines COVID treatments like Molnupiravir and Paxlovid Differences in COVID impact on nursing home residents and those with serious illnesses We wrap up with a “magic wand” question.

Vaccination 127

Vaccination IT Patient-Centered Patients 127