Entities / Entity
Center for Drug Evaluation and Research.
FDA research center
- Reports this week
- 0
- Active events
- 0
- Connections
- 15
What's happening
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What's reaching Center for Drug Evaluation and Research
Events traced to Center for Drug Evaluation and Research, step by step, newest first- CalciMedica's drug development requires CDER reviewCalciMedica's drug trial data requires review by CDERLikely
- Drug development for chronic cough increases CDER's review focusCDER's review workload increases as drug seeks approval for new chronic cough indicationsPossible
- New regulatory incentives may change how CDER evaluates drug submissionsNew regulatory incentives may change how CDER evaluates drug submissionsPossible
- CDER to review CBT-001 data for pterygium treatmentCDER must review CBT-001 data to determine pterygium drug pathPossible
- CDER faces March 2027 deadline for Anaphylm drug reviewCDER faces a critical March 2027 deadline for Anaphylm drug reviewLikely
- Stricter standards may require Center for Drug Evaluation and Research updatesStricter standards may require Center for Drug Evaluation and Research updatesPossible
See all 17 explainers
- InflaRx's drug trials require CDER's regulatory evaluationInflaRx's drug trials require CDER's regulatory evaluationPossible
- FDA's push for OTC estrogen may change drug review standardsThe Center for Drug Evaluation and Research may adjust standards for OTC hormone approvalLikely
- Standard product push may change drug evaluation criteria at Center for Drug Evaluation and ResearchA shift toward standard product approval could change evaluation criteria at Center for Drug Evaluation and ResearchPossible
- New drug submissions may increase workload for CDERNew drug submissions from Sanofi, Regeneron, and Bayer require review by CDERLikely
- Sovleplenib's designation triggers specialized review by CDERSovleplenib's Orphan Drug Designation requires specialized regulatory guidance from CDER.Likely
- VDPHL01 drug application requires review by FDA's drug evaluation centerThe Center for Drug Evaluation and Research must review VDPHL01's application for hair loss treatment.Likely
- BDR lawsuit could accelerate generic drug approvals at CDERBDR's lawsuit may force CDER to accelerate generic drug approvalsPossible
- CDER's drug evaluation process allows Arbutus Biopharma to advance its PD-L1 inhibitorCDER's drug evaluation process allows Arbutus Biopharma to advance its PD-L1 inhibitorAlready happening
- Adial's new AhR agonist may require FDA drug evaluation guidanceAdial's new drug development could engage FDA's drug evaluation centerPossible
- CDER evaluates adrabetadex for rare Niemann-Pick diseaseCDER evaluates adrabetadex for Niemann-Pick diseaseAlready happening
- Fast track designation speeds up drug review for neuropathic painThe Fast Track designation accelerates the drug review process managed by the Center for Drug Evaluation and Research.Likely
Around Center for Drug Evaluation and Research this week
News at the entities that move Center for Drug Evaluation and Research most-
FDA StructuralAnavex Life Sciences submitted data for FDA discussions and received scientific advice from the EMA.Moves Center for Drug Evaluation and Research
Connections
The 4 strongest of 15, analyzed from the reporting. The bars show how strongly a change on one side reaches the other.-
FDA Structural
The Center for Drug Evaluation and Research is a formal division overseen by the FDA agency.
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Michael Davis Structural
Michael Davis has been appointed to a permanent leadership role at the Center for Drug Evaluation and Research.
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Patrizia Cavazzoni Structural
Patrizia Cavazzoni holds a permanent director role at the Center for Drug Evaluation and Research.
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Michael Davis Structural
Michael Davis is appointed to the leadership role of director at the Center for Drug Evaluation and Research.