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Regulatory Intelligence & Drug Approvals2 months agoFDA Expedited Investigational New Drug (IND) Pilot Program
The FDA Expedited IND Pilot Program is an initiative under HHS Operation TrialBlazer designed to evaluate new approaches for accelerating first-in-human (FIH) clinical trials in the...
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Regulatory Intelligence & Drug Approvals2 months agoFDA opens Operation TrialBlazer for applications, hoping to reshore early trials
The FDA aims to leverage the expertise of qualified research institutions paired with drug sponsors to lessen the risk of clinical holds during the investigational new...
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Regulatory Intelligence & Drug Approvals2 months agoAn America First Approach to Medical Innovation
The FDA’s new Expedited IND Pilot will cut unnecessary delays in early-stage clinical research without compromising patient safety.
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Regulatory Intelligence & Drug Approvals2 months agoSTAT+: FDA takes applications for new program to shorten drug approval times
The FDA is opening applications for a pilot program designed to shorten drug approval timelines and help the U.S. compete with countries like China and Australia.
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Regulatory Intelligence & Drug Approvals2 months agoFDA launches pilot program to speed up early US drug research
First teased in June and formally announced Tuesday as part of “Operation Trialblazer,” the program will partner drugmakers with research institutions to more quickly bring medicines...
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Regulatory Intelligence & Drug Approvals2 months agoFDALabel: Full-Text Search of Drug Product Labeling
FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 160,000 labeling documents for FDA-approved drug products, including...
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Regulatory Intelligence & Drug Approvals2 months agoRare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting
The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that...
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Regulatory Intelligence & Drug Approvals2 months agoStakeholders urge FDA to define data, treatment standards as psychedelic drugs near market
Safety and access were top of mind at Monday’s public hearing exploring the regulation of psychedelic therapies. "The medicine opens the door,” NeuroAlchemy co-founder Michaela Vogt...
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Regulatory Intelligence & Drug Approvals2 months agoFDA Launches Expedited IND Pilot, Begins Accepting Applications
The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot.
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Regulatory Intelligence & Drug Approvals2 months agoSTAT+: Obesity drugmakers are testing in kids as young as 6
Vera seeks kidney drug approval, early data from Syntis Bio, and other biotech news from The Readout
LncRNA SBF2-AS1 Worsens Heart Injury After Attack via miR-149-5p/PHLPP2 Axis
Stigmatizing language found in over half of primary care patient records
Research report: The Influence of Renal or Hepatic Impairment on the Pharmacokinetics of Iclepertin (BI 425809): Results from Two Phase I Open-Label, Non-randomised, Single Dose, Parallel Design Studies
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
