US FDA updates guidance to speed up drug development

June 22 (Reuters) - The U.S. Food and Drug Administration said on Monday it is launching a series of measures to speed up ...
STAT

FDA drops enforcement against Whoop after it tweaks blood pressure feature

The FDA told wearable maker Whoop last week that it would not take further enforcement action over the company's blood ...
STAT

FDA’s breakthrough pipeline fills up with generative AI devices

Do health tracking apps and turmeric pills have anything in common? Several times while listening to Planet Money’s very fun and informative episode on dietary supplement regulation I thought to ...

FDA drops Whoop warning letter over blood pressure feature

Whoop made changes to its blood pressure insights feature that satisfied the FDA’s requirements for wellness devices.
MobiHealthNews

FDA closes warning letter to Whoop for blood pressure insights feature

The agency said it closed its warning letter against Whoop after the wearable company modified its Blood Pressure Insights ...
Regulatory Affairs Professionals Society

HHS and FDA propose clinical trial reforms to expedite drug development

The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will ...
Medical Device and Diagnostic Industry (MD+DI)

FDA Clarifies When Software & Wellness Products Are Not Medical Devices

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory classifications.

FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health ...
Regulatory Affairs Professionals Society

FDA revises master protocol guidance with new section on basket trials

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...
Medical Device and Diagnostic Industry (MD+DI)

FDA Backs Down on Whoop Blood Pressure Monitoring Dispute

FDA has closed its July 2025 warning letter to wearable fitness tracker maker Whoop regarding the company's Blood Pressure ...

FDA says Amazon violated federal regulations with sale of unapproved penile creams

The federal agency purchased three creams through Amazon's website. The FDA described all three as unapproved drugs that are ...