Keep an eye on drug approvals, special designations, and clearances from governing authorities across the globe. With 8 variations of regulatory events tracked, you’ll see crucial milestones that directly impact a drug's development pathway and market viability.
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.
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.
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.
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.
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.
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.
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.
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.
Get data readouts from dozens of trial registries, scientific publications, and sponsor announcements, including data that has yet to be presented publicly. All relevant information is packaged and organized for you so you can make sense of it quickly.
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Track changes in recruitment statutes, actual versus targeted patient enrollment, and irregularities across 11 event variations so you can accurately assess the feasibility and timeline of any clinical trial.
Follow across 5 event types that highlight the latest innovations in clinical development, such as new trial registrations, partnership announcements, INDs, and first patients dosed. As new treatments, companies, and drugs enter the space, you’ll be the first to know.
Watch over setbacks and accelerations in trial completion dates with 6 event types that highlight the varying levels of risk or progression. Link each event type with associating factors like regulatory updates, recruitment activities, and more.
Know the current status and future trajectory of any study through our 8 event variations that cover a trial from beginning to end. Milestones like completing a phase or resuming after a suspension ensure that you’re always kept in the loop.