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FDA Punts To Congress On CBD Regulation: “New Pathway” Debate Will Reinforce Likelihood That Broader Drug Regulatory Topics Stay Out Of Political Spotlight
January 26, 2023
Cidara/Melinta’s Rezafungin On Track To Be First “Limited Use” Antifungal After Positive Committee Vote; Once-Weekly Dosing Viewed As Clear Clinical Advantage
January 26, 2023
Prevision Policy Clips | House Democrats Establish Committee Membership with New Jersey’s Frank Pallone
January 26, 2023
Prevision Policy Clips | Another AA Review By ODAC: Genentech Polivy Will Be Reviewed March 9 For First Line Indication
January 25, 2023
Prevision Policy Clips | Makena Gets Closer To Forced Withdrawal: Presiding Officer Celia Witten Agrees With CDER, Hearing Outcome
January 24, 2023
COVID Vaccines Moving To Flu Model: FDA Advisory Committee Will Be Asked To Ratify “Simplified” Annual Strain Selection Process
January 23, 2023
FDA Sticks To Orphan Drug Exclusivity By Indication, Despite Catalyst Ruling; Clarity For Now – But More Litigation Likely
January 23, 2023
Prevision Policy Clips | FDA Responds To Catalyst Ruling At Last: No Change In Orphan Drug Exclusivity Policy Going Forward
January 23, 2023
Cidara/Melinta’s Antifungal Rezafungin Likely To Have Limited Use Indication Only; Ad Comm Told That FDA Does Not Believe Broader Claim For Candidiasis Is Supported By Available Data
January 20, 2023
Prevision Policy Clips | Lilly’s Donanemab For Alzheimer’s Gets CRL For Accelerated Approval, But May Mean Little If Timeline Holds
January 20, 2023
Prevision Policy Clips | MPox Drug Development Draft Guidance Announced By FDA January 19
January 19, 2023
FDA Oncology Dose Optimization Guidance: Randomize Where Feasible, Breakthrough Status Does Not Obviate Obligation To Find Optimal Dose Pre-approval
January 18, 2023
Prevision Policy Clips | RSV Adult Vaccine Race Heats Up: Moderna To Submit BLA To FDA In The First Half Of This Year
January 18, 2023
IRA Impact On Small Molecule Development: MedPAC Member Argues That Part D Redesign, Proposed Part B Reforms May “Cancel Out” Price Negotiation Disincentives
January 17, 2023
The Part D Baseline: MedPAC Will Be Watching For Impact Of Plan Changes On Beneficiary Access And Choices During IRA Implementation Period
January 17, 2023
Prevision Policy Clips | FDA Dose Optimization Draft Guidance For Cancer Drugs Builds On OCE’s Project Optimus, Not For Gene And Cell Therapies
January 17, 2023
Prevision Policy Clips | CMS Opens National Coverage Review Of ViiV’s Apretude For PrEP
January 13, 2023
FDA Gets Granular On Dose Labeling: New Guidance On “Dosage & Administration Section” Dramatically Expands Advice And Examples From 2010 Predecessor
January 12, 2023
Medicare Price Negotiation Implementation Timeline Unveiled By CMS: “Small Biotech” Exception Is First Action Item, Overall Guidance Due By Summer
January 12, 2023
Prevision Policy Clips | FDA Updating Guidance On “Dosage & Administration” Section Of Labeling
January 12, 2023
Regeneron Eylea Pediatric Use Labeling Review: Unusual Task For FDA Advisory Committee Goes Well For VEGF-Inhibitor
January 11, 2023
Prevision Policy Clips | FDA’s Wilson Bryan To Discuss Evolution Of OTAT To Super Office At Feb. 13 Biopharma Congress
January 11, 2023
FDA Plans To Finalize OTC “Safe Use” Pathway In 2023, Updated Regulatory Agenda Says
January 11, 2023
FDA’s Very Big Year: A Guide To Legislation Enacted In 2022
January 11, 2023
FDA Chiefs Chat: Former Commissioners Debate Impact Of IRA On Drug Development, Linking Accelerated Approval To Reimbursement
January 10, 2023
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