Clearance

The trial, its subsequent phase, or the enrollment has received clearance from a regulatory authority, which may also signify the revocation of a clinical hold. The FDA's IND application approval is a prerequisite for starting clinical trials, ensuring the volunteers aren't exposed to undue risks. Clinical announcements related to clearances constitute approximately 2.5% of all such updates detected by AppliedXL.

Priority Review

The intervention is under Priority Review, aiming to expedite the drug's development and review. This means the FDA targets action within six months rather than the standard ten. Though it doesn't alter the approval standard, it does provide additional guidance for drug development. Priority Review-related press releases are less than 1% of all clinical announcements tracked by AppliedXL.

Breakthrough Designation

The intervention has been labeled a Breakthrough Therapy, speeding up drug development for severe conditions when preliminary data suggests significant improvement over existing treatments. Drugs with this designation gain advantages like comprehensive FDA guidance. Press releases on Breakthrough designation are under 1% of those monitored by AppliedXL.

Regulatory Approval

The intervention has gained official regulatory approval, indicating it's effective, and its benefits surpass the risks as per approved labeling. Once approved, it can be marketed and prescribed. These approvals make up roughly 4% of all clinical press releases identified by AppliedXL.

Emergency Use Authorization

The intervention has been permitted for emergency use to counteract serious threats. The FDA issued numerous EUAs during the Covid-19 crisis. Overall, EUA announcements account for approximately 0.3% of clinical press releases tracked by AppliedXL.

Fast Track Designation

The intervention has acquired Fast Track designation, accelerating the development of drugs addressing serious conditions and unmet medical needs. Such drugs benefit from closer and more frequent interactions with the FDA. Fast Track-related announcements comprise slightly under 1% of all press releases monitored by AppliedXL.

Regulatory Action

A regulatory body has taken action with ramifications on one or multiple trials. This could include granting an orphan drug designation, approving protocol amendments, and more. About 5% of all clinical press release updates detected by AppliedXL fall under this category.

Submission

A sponsor has forwarded an application for the trial's next steps to the relevant regulatory authority. Such submissions provide insights into anticipated future actions and timelines. Submission-related announcements represent just over 2% of all clinical updates tracked by AppliedXL.