In January 2024, an ASCO-led, multistakeholder group published a call to action to advance patient-focused DCTs. 20 It identified FDA's Statement of Investigator Form (Form 1572) as a key barrier, ...

Food and Drug Administration regulators on Tuesday approved the drug tofersen, a first-of-its-kind treatment for a rare, inherited form of ALS.

After an FDA inspection of a Torrent Pharmaceutical manufacturing facility in Gujarat, India, the agency has handed the company a Form 483 filing citing several production shortfalls.

The FDA, which issued India’s Laurus Synthesis a Form 483 in January, followed up the action with an "untitled letter" that outlined the Indian drugmaker’s problems with its quality control ...

WASHINGTON (AP) — The first gene therapy for a deadly form of muscular dystrophy received preliminary U.S. approval on Thursday despite concerns from some government scientists about the ...

The inspection concluded with a Form 483 containing several observations. Capricor said it has submitted its responses to the FDA, none of which required material changes to the cGMP process or ...

As per the US FDA, for inspectional purposes, the address listed in Form 1572 should be the physical location where all trial-related records are accessible and where the investigator is located and ...

On Tuesday, April 25, 2023, the FDA approved tofersen, a first-of-a-kind drug for a rare form of Lou Gehrig’s disease, though they are requiring further research to confirm it truly helps patients.

Food and Drug Administration regulators on Tuesday approved a first-of-a-kind drug for a rare form of Lou Gehrig’s disease, though they are requiring further research to confirm it truly helps ...

FDA Approves Drug for Rare Form of Lou Gehrig's Disease Approval came via FDA’s accelerated pathway, which allows drugs to launch based on promising early results, before they’re confirmed to ...