Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...

Biopharmas looking to submit a drug ... the data they include—good and bad—and they should get in touch with the agency as early as possible. That’s the headline from new draft guidance ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.

Yet if formalized, the guidance could facilitate the ability to use RWE to update a drug’s label with new effectiveness or safety data, say, in a subpopulation or patient group whose numbers perhaps ...

The FDA published final guidelines for applicants submitting biologics license applications or new drug applications in its real-time oncology review pilot. The final version states eligible ...