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FDA, animal testing and Monoclonal antibody

FDA plans to phase out animal testing in drugs in what it calls a ‘paradigm shift’

The move comes after lawmakers sought to force the agency to update regulations that would allow alternatives to animal testing.

FDA says it will phase out animal testing requirement for monoclonal antibodies and drugs

The US Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies and other drugs be tested on animals, saying in a news release that there are “more effective,

Fierce Biotech · 5h

FDA plans to end animal testing requirements for monoclonal antibody drugs

The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal antibodies and some other drug candidates. | The FDA announced on April 10 that the agency plans to end the requirement for new monoclonal antibodies and some other drugs to be tested in animals.

The Christian Post on MSN1d

Trump's FDA head Marty Makary calls 'soul care' essential to health, warns spiritual needs often 'neglected'

President Donald Trump's newly confirmed Food and Drug Administration Commissioner, Dr. Marty Makary, emphasized that “soul ...

FDA Commissioner Marty Makary gets off to a bruising start as agency is wracked by layoffs

A national leader in medicine with impeccable credentials, Dr. Makary is imminently qualified to lead the FDA at this ...

17hon MSN

FDA reverses course on telework after layoffs and resignations threaten basic operations

WASHINGTON (AP) — Weeks after ordering all Food and Drug Administration employees back into the office, the agency is ...

Physicians Committee for Responsible Medicine2h

Physicians Committee Applauds FDA Commissioner Makary’s Leadership on Phasing Out Animal Testing in Favor of Human-Relevant Methods

The Physicians Committee for Responsible Medicine, a nonprofit that advocates for nonanimal science, is applauding the new ...

2hon MSN

RFK Jr. Warns FDA Staff of ‘Deep State’ in All-Hands Meeting

Robert F. Kennedy Jr. warned Food and Drug Administration staff about the influence of the “deep state” on the agency in an ...

1h

RFK Jr. calls FDA a 'sock puppet' for industries in private speech to agency staff

Health Secretary Robert F. Kennedy Jr. spent a portion of his speech on Friday to FDA staff deriding their past decisions, at ...

1d

FDA reverses RTO mandate and restores telework for key staff

Whatever the reasoning behind the telework shift, former federal officials say it’s a sign that recently confirmed FDA ...

Makary’s first speech to FDA staff focuses on challenging norms, fighting chronic disease

In recording, Makary said little about specific plans for his agency or about the layoffs that have roiled his workforce.

11don MSN

New FDA commissioner agreed to oust top vaccine regulator after private swearing in

The forced removal was Makary’s first major act as commissioner and sent a powerful signal to a stunned Washington that was ...

MedPage Today on MSN3d

New Advisor to FDA Chief Pushed Back on COVID Policies

Tracy Beth Høeg, MD, PhD, who was named a special assistant to new FDA Commissioner Marty Makary, MD, MPH, previously opposed ...

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