US WorldMeds, LLC
http://www.usworldmeds.com/
Questions?
Please contact Sales at: (212) 520-2765 or email [email protected]
Latest From US WorldMeds, LLC
Confirmatory Evidence: FDA Guidance Allowance For Use Of Animal Data Draws Split Views
Industry comments also seek more specificity on the types of real-world data that could supplement a single adequate and well-controlled trial to demonstrate substantial evidence of efficacy, and clarification as to whether confirmatory evidence can come from the same single clinical study.
Real-Time Oncology Review Speeds Supplements At US FDA, But Gives Modest Benefit For Novel Agents
US FDA’s 72 approvals under streamlined submission program consistently come before the PDUFA goal date, Pink Sheet analysis shows, but benefit ranges from 2 weeks for priority review novel agents to 1.8 months for other priority applications.
Breakthrough Bounceback Looks Unlikely At US FDA’s CDER, But CBER Is Riding Wave Of RMATs
Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.
US FDA’s Eflornithine Review Is Showcase For Deep Oncology Team
The advisory committee review of US WorldMeds’ eflornithine for neuroblastoma was remarkable for the unusual nature of the efficacy data to support the NDA – and also for who spoke on behalf of the agency and how effectively they walked the panel through a complex set of issues.
Company Information
- Industry
- Pharmaceuticals
-
Pharmaceuticals
- Generic Drugs
- Specialty Pharmaceuticals
- Other Names / Subsidiaries
-
- Sloan Pharma S.a.r.l
- Solstice Neurosciences
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Company
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
DCD.EmailPopout.Notice