Prevision Policy Clips | FDA Will Present Updated COA “Evidence Dossier” Template At Sept. 18-19 Workshop

Prevision Policy Clips | Kennedy Plays Defense: HHS Secretary Says “The Swamp” Out To “Drive A Wedge” Between MAHA And Trump

Prevision Policy Clips | Prasad Speaks: “Randomized Trials Are Not Always Needed” For FDA Approval

White House EO On APIs Directs ASPR To Create “Most Critical Medicines,” Update “Essential Medicines” Lists

Prevision Policy Clips | FDA Has Received “A Great Deal Of Interest” In Commissioner’s Priority Voucher: Assessments Will Be Made “On A Rolling Basis”

Scholar Rock’s Apitegromab Misses The Mark At ICER’s SMA Review Meeting; Panel Overwhelmingly Finds A Lack Of Evidence For Add-On Therapy After Zolgensma

Prevision Policy Clips | CBER Org Chart Update Shows Vinay Prasad As CBER Director; OTP Yet To Recover From Deterioration

Prevision Policy Clips | USPTO Signals Reluctance To Take Administrative Action On Patent Reform, Warns Against Overregulation In FTC/DOJ Drug Pricing

Drug Quality Assurance Inspections Are Closer To Pre-Pandemic Levels, But Still Behind; China Leads Jump In Foreign Sites, CDER Report Finds

FTC/DOJ On Drug Pricing: “Balance” Needed Between Patent Rights And Reforms; USPTO Warns Against Overregulation In Final Listening Session

Prevision Policy Clips | Vinay Prasad’s Return To FDA: Move Signals Continued Volatility At Agency; A Fragile Stability Could Be Best-Case Scenario

Prasad’s Return To FDA Puts Center Consolidation Plan On Back Burner (Again), But Does A Window Remain Open For OCE 2.0?

Makary’s Prodigal Son Returns: Prasad’s Rebound At FDA Underscores Continued Volatility At Agency; Will A Fragile Stability Emerge?

Prevision Policy Clips | FDA Commissioner Makary On Lessons Learned From CEOs: "They Want Better Communication"

FDA “PreCheck” Domestic Manufacturing Proposal Features Pre-Operations Phase 1, Phase 2 To Offer “Advanced Awareness” Of Strategies For Specific Drugs

Prevision Policy Clips | Onshoring Drug Manufacturing: FDA To Present “PreCheck” Framework At Public Meeting Sept. 30

Bristol’s Persistence In Pursuing Breyanzi NTAP Wins CMS Acceptance For Two Indications; CMS Grants Seven New Drug Add-On Payments For FY2026

Prevision Policy Clips | HHS Ends mRNA Vaccine Development Under BARDA: "No New mRNA-Based Projects Will Be Initiated"

RWE In 2025: Focus Should Be On “Methodologic Expertise,” Transparency Measures; Some Stakeholders Call For Updates To FDA Guidances

Prevision Policy Clips | FDA Chief Counsel Is Sean Keveney

FDA Deadline Tracker: A “Record Year” For NMEs? Commissioner Makary Aiming High Despite Ongoing Turmoil At The Agency; Other Deadlines May Suffer

Prevision Policy Clips | FDA And CRLs: Prevision Policy Analysis of 283 Letters Shows Adverse Inspection Findings

Opioid Safety: FDA Requiring Class Labeling With Risks Seen In Observational Studies; Adcomm Had Cautioned Against Incorporating Specific Data

FDA’s CRLs By The Numbers: Inspections, Product Quality Are Most Common Reasons For Rejections; 505(b)(2) NDAs Dominate First Batch Of Letters Released By Agency

Prevision Policy Clips | Trump Repeats MFN Threat; Gives Companies Another 60 Days