If you are pregnant or nursing, talk with your health care professional about whether to enroll in pregnancy safety or ...

The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...

More than 10 million babies have been born through IVF, yet the process is still invasive and costly. Plus, why a venture ...

The novel formulation of rizatriptan and meloxicam (Symbravo, Axome Therapeutics) is for the acute treatment of migraine with ...

What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

When politicians subordinate scientific institutions to electoral interests, they undermine immediate public health efforts ...

The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...

The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

Robert F. Kennedy Jr., President Donald Trump's pick to lead the top U.S. health agency, told U.S. senators during his ...

On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...

The website changes raise concerns about “the interference of politics with the study and the practice” of science and medicine, one physician said.

Note that all Canada-specific data requirements for new drug submissions (NDS ... we do not review the information for its compliance with the regulations. Examples of unsolicited information include ...