Adaptive Trials

Adaptive Trials Offer Potent Weapon Against Phase 3 Failures

Video Podcast: Innovation in Clinical Trial Execution for Adaptive Trials

The 2014 ADDPLAN® DF Consortium: Advancing Adaptive Design for Dose-Finding Clinical Trials

Video Podcast: Streamlining Endpoint Adjudication

Dr. Vladimir Dragalin Interviewed By Technology Networks On ADDPLAN® Software

Eli Lilly Executive Advocates Adaptive Trial Design

Medical Device

FDA Warning Letter Data Shows Improvement in 2013

FDA Guidance Discusses UDI Labeling Requirements For Small Medical Device Manufacturers

FDA IT Upgrades To Improve Medical Device 510(k) And De Novo Processes

Apple Bars Medical Device Apps From iCloud Data Storage Service

Why Manufacturers Should Design Medical Devices Geared Towards Women

New De Novo Draft Guidance For Medical Device Companies

Drug Development

FDA Releases 2 Refuse To Receive Guidances for ANDAs

FDA Issues Guidance on Generics Controlled Correspondence

FDA Explores Proprietary Name Reservation for Drug Products

FDA Published In Vitro Companion Diagnostic Device Guidance

Verifying 100% of Source Data May be Unnecessary

The NIH Provides Assistance to New and Early Stage Investigators