The American Journal of Managed Care6h
FDA Quietly Removes Draft Guidance on Diversity in Clinical Trials Following Executive Order on DEI
The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...
STAT18h
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 ...
clinicaltrialsarena on MSN1d
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The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.
JD Supra1d
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
JD Supra2d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
Rolling Out2d
Why the FDA says menthol cigarettes must go now
The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...
News Medical on MSN1h
New FDA initiatives focus on medication safety for pregnant and nursing women
If you are pregnant or nursing, talk with your health care professional about whether to enroll in pregnancy safety or ...
Well+Good5d
Could New Government Changes Affect the Safety of Your Beauty Products?
If you ask Robert F. Kennedy Jr., Americans are incredibly unhealthy—and he’s on a mission to Make America Healthy Again (MAHA). He first began campaigning as an independent presidential ...
As Trump and RFK Jr. move to upend drug making, Seattle biotech bets on science
Robert F. Kennedy Jr. may soon be America's top pharmaceutical regulator. That is cause for concern in Seattle’s biotech ...
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 ...
Liberty human tissue bank sues FDA over regulation of umbilical cord product
Liberty-based Vitti Labs, a human tissue bank, is suing the Food and Drug Administration over how the agency is regulating a ...
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 ...