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FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
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FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
STAT7d
FDA purges material on clinical trial diversity from its site, showing stakes of Trump DEI ban
Following the Trump administration's DEI ban, the FDA's move to scrub webpages has ensnared many pages focused on ensuring ...
STAT7h
How to protect HHS, FDA, NIH, and other health agencies from political interference
When politicians subordinate scientific institutions to electoral interests, they undermine immediate public health efforts ...
FDA approves Vertex's first-in-class non-opioid analgesic for acute pain
Today, the U.S. Food and Drug Administration (FDA) gave its approval to Vertex Pharmaceuticals' (NASDAQ: NASDAQ:VRTX) ...
Bird Flu Concerns Prompt New FDA Guidance on Raw Pet Food Safety
MONDAY, Jan. 27, 2025 (HealthDay News) -- Reports of cats becoming seriously ill or dying after consuming raw pet food or ...
Healio1d
Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
policymed.com7d
Final FDA SIUU Guidance: Understanding the Key Updates and Resources
In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...
medtechdive3d
FDA webpages on clinical trial diversity removed after Trump orders
The website changes raise concerns about “the interference of politics with the study and the practice” of science and ...
Truthout3d
Trump Aims to Overhaul the FDA. What Does That Mean for Public Health?
Meanwhile, in an executive order, Trump created his long-discussed “Department of Government Efficiency,” to be led by Elon ...
FDA Opens Up A New Path To The U.S. Market For This Under 30 Biotech Startup
More than 10 million babies have been born through IVF, yet the process is still invasive and costly. Plus, why a venture ...
Rolling Out7d
FDA unveils 8 critical safety measures for berry industry
FDA introduces comprehensive safety measures targeting norovirus and hepatitis A in fresh and frozen berries, addressing ...