The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.

The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...

Would you like to become a test subject for medical studies? Here is everything you need to know about paid clinical trials ...

Many clinical trials aren’t able to even move past the recruitment and enrollment stage. According to Deloitte, a “study on ...

Effective strategies in funding, patient recruitment, and technology are crucial for the success of rare disease trials ...