The FDA has introduced ELSA, a groundbreaking AI tool designed to expedite the review process for drugs and medical devices.

Several of the committee members asked at Thursday’s meeting about the FDA’s new vaccine approval framework. Some expressed ...

Documents show "the agency’s review and approval process for Aduhelm was highly atypical and deviated from FDA’s guidance and procedures in significant respects,” the report by the House ...

Many physicians have only a hazy understanding of the FDA's approval process for new drugs and medical devices, a national survey found. Of 509 physicians surveyed, 41% reported a "moderate" or ...

Judge Matthew Kacsmaryk also cites accelerated approval in his ruling. The FDA did not use that part of the law in its process, however. This isn't the first time there have been allegations that ...

"As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval," the letter said.

To earn FDA approval, manufacturers undergo a five-step process that includes: This process can stretch over a decade. While not flawless (hello, recalls), it’s the highest level of scrutiny for ...

Physicians’ knowledge of the FDA’s approval process is important in informing clinical decisions and patient discussions. In recent years, several aspects of the FDA review process have changed, ...