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Real-World Evidence In NDA Reviews: FDA Reports Four Approvals Supported By RWE In FY23; Dose Modification For UCB’s Vimpat Is Rare Case Of RWE As Main Evidence
June 28, 2024
Advisory Committee Tracker: AstraZeneca Imfinzi sBLA Will Test FDA’s “How Much Is Enough?” Concerns At ODAC; Committee Meetings Still Lagging In 2024
June 28, 2024
Prevision Policy Clips | Medicare Oral Phosphate Binder Payment Shift Will Increase Spending By $180 Million In 2025, CMS Says
June 28, 2024
Medicare Coverage Of Obesity Drugs: “First Step” May Be Access For Current Users Who Join Program; Narrow House Bill Moves Forward Amid Calls For Price Scrutiny
June 27, 2024
Getting “Digital Endpoints” Right: Clinical Goals Should Drive Technology Development – Not The Other Way Around, FDA’s Sacks Tells FNIH Workshop
June 27, 2024
Prevision Policy Clips | Medicare Weight Loss Drug Coverage Bill Heads To Mark-Up June 27: Modified House Bill
June 27, 2024
Diversity Action Plan Guidance: FDA Wants DAPs By End-Of-Phase II Meeting, Says Waivers Will Be Rare; Requirement On Track To Kick In For 2026
June 27, 2024
Prevision Policy Alert: FDA Posts Diversity Action Plan Draft Guidance
June 26, 2024
Prevision Policy Clips | BIOSECURE Act Is Budget Neutral, CBO Reports
June 26, 2024
Prevision Policy Clips | Diversity Action Plan Guidance Clears OMB: FDA Implementation Of New FDORA Mandate Should Begin About Six Months Late
June 25, 2024
FDA Rare Disease “Innovation Hub” Is Born Out Of Cross-Center Agenda; CBER’s Marks Is Taking The Lead With Communication An Initial Focus
June 24, 2024
RWE-Only To Support A New Indication? "Yes, Potentially," FDA's Concato Says
June 24, 2024
Prevision Policy Clips | LDT Small Entity Compliance Guide Issued By FDA
June 24, 2024
N of 1? CBER’s Marks Again Overrules Staff In Granting Sarepta DMD Gene Therapy Label Expansion; One Last Regulatory Checkpoint Due In 2027 With ENVISION Trial
June 21, 2024
Prevision Policy Clips | Sarepta DMD Gene Therapy Label Expansion: CBER Director Marks Again Overrules Staff
June 21, 2024
Interchangeable For All? Switching Studies May Be Unnecessary For Interchangeable Biosimilar Designations, FDA Says In Draft Guidance
June 20, 2024
Advisory Committee Listening Session: Industry Mostly Sits Out FDA Feedback Meeting; AbbVie Registers Preference For Separate Documents, Elevated Patient Voice
June 20, 2024
Prevision Policy Clips | “Interchangeable” Biosimilar Guidance Update: FDA Says Switching Study Standards Have “Evolved”
June 20, 2024
Prevision Policy Clips | HHS OIG Allows Financial Assistance For Sickle Cell Gene Therapy In June 17 Opinion: Travel, Lodging, Meals, And Associated Expenses
June 18, 2024
CMMI Accelerated Approval Model May Not Advance “As Fast As Initially Proposed”; Sickle Cell Disease Model Has Received Letters of Intent From States Covering 80% Of SCD Patients
June 17, 2024
Prevision Policy Clips | CDER Artificial Intelligence Policy Lead Is Tala Fakhouri
June 17, 2024
CBER Office Of Therapeutic Products Leadership Trying To Increase Consistency Across Gene/Cell Therapy Reviews; Hiring Is Strong For Clinical, CMC Positions
June 14, 2024
Lilly’s Donanemab Positive FDA Panel Paves Way To Early Alzheimer’s Treatments; Tau Staging Not A Prerequisite
June 14, 2024
Prevision Policy Clips | FDA Recommends KP.2 Strain Vaccine For 2024-2025 COVID Vaccine Formula, Defying Advisory Committee Recommendation
June 14, 2024
“Onshoring” Solutions Are Not A Panacea For Drug Shortages, Generic Industry Cautions; Shift Towards Payment For Resiliency As Solution Evident At Duke Policy Meeting
June 13, 2024
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