Request Processed
Your registration request has been processed. We will contact you soon.
Register
First name
Last name
Email
Company
Toggle navigation
Toggle navigation
Login
Register
About
Contact Us
1
2
3
4
5
…
Next ›
Last »
FDA Foreign Inspections “On The Way Back” But “Not There Yet,” Califf Tells House Appropriators; Return To Cordial Tone In FDA Oversight On Hill
April 18, 2024
Prevision Policy Clips | House Republicans Criticize FDA Lab-Developed Test Regulation Proposal At HHS Budget Hearing
April 18, 2024
Prevision Policy Clips | OCE “Project Asha” Collaboration With India Will Focus On Clinical Trials And Research Training
April 17, 2024
Prevision Policy Clips | Prepping For PrEP To Move From D To B: CMS “Fact Sheet” Outlines Transition Process
April 16, 2024
CDER Trial Innovation Center (C3TI) Will Be “Central Hub” For Innovative Approaches, Including Pragmatic Trials; Former “Warp Speed” Chief Of Staff Bugin Will Lead Effort
April 15, 2024
Sickle Cell Gene Therapies Would Have Enhanced Payment For Inpatient Use Under CMS Proposal For FY 25; Six Other New Drugs/Biologics May Qualify For NTAP Class Of 2025
April 15, 2024
“Minimal Residual Disease” Is An Acceptable Accelerated Approval Endpoint In Multiple Myeloma, ODAC Says; FDA’s Withdrawal Authorities Make For Easy Vote
April 15, 2024
Prevision Policy Clips | “Point/Counterpoint” Advisory Committee Joint Documents Will Be “Default” For ODAC
April 15, 2024
FDA’s Case For Stronger Shortage Authority Pressed By Califf In Contentious House Oversight Hearing; Partisan Attacks Break With Recent Treatment Of Agency On Hill
April 12, 2024
Prevision Policy Clips | Sickle Cell Gene Therapies Are Bright Spot For Commissioner Califf
April 12, 2024
OGD Picking Up The Pace: ANDA Review Times Are Getting Faster, FDA Officials Tell Generic Drug Forum; GDUFA III Changes Are Helping
April 11, 2024
Prevision Policy Clips | Diversity Action Plans Guidance Heads To OMB For Review
April 11, 2024
“Minimal Residual Disease” Accelerated Approval Endpoint In Multiple Myeloma Supported By “Robust Data,” FDA Says Ahead of ODAC Meeting
April 10, 2024
Prevision Policy Clips | Xtandi Critics Try Another Long-Shot Price Cut Request: Letter To CMS
April 10, 2024
Prevision Policy Clips | 340B Program Office Has Permanent Head: Chantelle Britton
April 9, 2024
Prevision Policy Clips | J&J/Legend Carvykti Label Expansion Clears FDA; “Early Mortality” Warning
April 8, 2024
Prevision Policy Clips | FDA Commissioner Califf Will Testify At April 11 House Oversight Hearing: Drug Shortages, Inspections
April 5, 2024
HHS Considering “Manufacturer Resiliency Assessment Program” Based On Non-Governmental Accrediting Group As Part Of Shortage Response Plan
April 4, 2024
Prevision Policy Clips | Amylyx Withdrawing Relyvrio: Quick Closure Is Best Possible Outcome For FDA
April 4, 2024
The New Part D: CMS Finalizes 2025 Guidance For Plans; Formula For Specialty Tier Coinsurance Changes, But Range Remains 25%-33%
April 3, 2024
Prevision Policy Clips | Minimal Residual Disease Advisory Committee Discussion May Be “Highly Controversial”
April 3, 2024
FDA Urging Caution When Selecting BA/BE Testing Site Partners: Sponsors Should Confirm Quality Management Is In Place – And Report Fraudulent Behavior
April 2, 2024
Prevision Policy Clips | FDA Continues Focus On BA/BE Data Integrity With New Draft Guidance
April 2, 2024
Bioequivalence Test Sample Handling: FDA Warns Of “Concerning” Practices In Updated Guidance; Reduces Minimum Retention Amount Based On Newer Test Methods
April 1, 2024
Prevision Policy Clips | JAMA Cost-Based Pricing Analysis Of Antidiabetics Prompts Sen. Sanders To Call For Lower Wegovy Pricing
April 1, 2024
1
2
3
4
5
…
Next ›
Last »