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Part B Update Rules: CMS Proposes “Guardrails” For Service Fees; Plans Acquisition Cost Survey That Could Lead To 340B Payment Cuts In 2027
July 18, 2025
Novel Combination Regimens In Oncology: FDA Outlines Cases Where Sponsors Can Use External Data Rather Than Traditional Factorial Trials
July 18, 2025
GSK Blenrep ODAC Turns Into Bad Dream: Reapproval Bid Based On DREAMM-7/8 Trials Voted Down Due To Dose Issues, Lack Of US Subjects
July 18, 2025
Prevision Policy Clips | CDER Director Selection Is “Close,” Commissioner Makary Says
July 18, 2025
Real-Time Release Of CRLs Is FDA’s Goal, Commissioner Makary, CBER Director Prasad Affirm; Makary Reiterates Prediction Of “Record Year” For Drug Approvals In 2025
July 17, 2025
Prevision Policy Clips | FDA Commissioner Makary’s Voucher Program Would Promote “Pet Projects”
July 17, 2025
Otsuka/Lundbeck Rexulti For PTSD: FDA Wants Committee Vote On Whether Single Trial Can Support Approval With Uncertain Supportive Evidence; Leaves Opening For “Yes” Vote
July 16, 2025
Prevision Policy Clips | Direct-To-Consumer Advertising Targeted In Vaccine Injury Hearing
July 16, 2025
GSK Blenrep Reapproval Request: FDA Remains Concerned About Ocular Toxicity And Dose Selection; Potential Split Decision On Two Proposed Indications From ODAC?
July 15, 2025
Prevision Policy Clips | 60 NMEs In 2025? Commissioner Makary Suggests FDA Will Approve “At Least 20%” More
July 15, 2025
PDUFA VIII: Commissioner Makary Suggests Lower Fees Could Be One Goal, CEO “Listening Tour” Starts Focus On Communication, Predictability
July 14, 2025
Prevision Policy Clips | Commissioner’s Voucher As Incentive For Price Reductions? FDA Commissioner Makary
July 14, 2025
GDUFA IV Gets Underway: Makary Highlights Supply Chain Improvements During Kick-Off Meeting; Industry Asks For Continued Focus On Complex Generics
July 13, 2025
Remote Regulatory Assessments: FDA Clarifies That “Mandatory” RRAs May Still Include “Voluntary” Requests In Final Q&A Guidance
July 11, 2025
Prevision Policy Clips | Senate Appropriators Advance Flat FDA Funding For FY 2026: Improvement On House Version
July 11, 2025
FDA Posts Past Rejection Letters To Centralized Database For Approved Products; Non-Disclosure Policy For Unapproved Applications Remains In Place
July 10, 2025
FDA Pediatric Advisory Committee Member’s Call For Enhanced Monitoring Of Adverse Event Reports May Resonate With New Leadership
July 10, 2025
Prevision Policy Clips | FDA Makes Access To Already Public Rejection Letters Easier
July 10, 2025
Myelodysplastic Syndrome: FDA Affirms Viability Of Transfusion Independence As Efficacy Endpoint; Guidance Is First New Drug Development Advice Of Makary/Trump Era
July 9, 2025
Prevision Policy Clips | Senate FDA Appropriations Mark-Up Set For July 10
July 9, 2025
Reducing Animal Testing: New Biologics Pathway Modeled On 505(b)(2) Could Help, FDA Staff Tell Commissioner; Workshop Follows “Roadmap” On Alternatives To Animal Testing
July 8, 2025
FDA AI “Opt-In”? Agency May Ask Sponsors For Permission To Train AI Models Using NDA/BLA Data; Alternatives To Animal Testing Could Be Test Case
July 8, 2025
RTOR Tracker: FDA “Real Time” Review Use Picked Up In 2024 As Interest In Expansion Outside Oncology Increases
July 8, 2025
Prevision Policy Clips | Ending Animal Testing: FDA May Ask Sponsors For Permission To Train AI
July 8, 2025
Prevision Policy Clips | HR 1 Signed Into Law: Orphan Drug “Negotiation” Exemption Expanded, But Long Term Impact On Insurance Coverage
July 7, 2025
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