Prevision Policy Clips | Biosimilar/Interchangeable FDA Labeling Draft Guidance Builds On Earlier General Principles

Alnylam’s Onpattro For Cardiomyopathy Secures Cardio-Renal Advisory Committee Recommendation On “Light Wind” Of Benefit, No Risks

Prevision Policy Clips | FDA Office Of Immunology And Inflammation Acting Deputy Director Is Kathleen Donohue

Prevision Policy Clips | CMS Acting Chief Medical Officer Dora Hughes To Testify At House Energy & Commerce Health Subcommittee Hearing Sept. 19

ORA Reorg To Include Inspectors Trained In Real-World Evidence, FDA’s Califf Says; Commissioner Pushes RWE To Guide Use Of Alzheimer’s, Obesity Drugs

Prevision Policy Clips | FDA Commissioner's Senior Clinical Advisor For Chronic Disease Is Brigham & Women’s Cardiologist Haider Warraich

Alnylam Onpattro For ATTR-CM: FDA Seeking Cardio-Renal Committee View On Extent Of “Clinically Meaningful” Effect; FDA Review Team Not Convinced

Prevision Policy Clips | Regeneron “Substantially Equivalent” Ex-US Pricing Clause In Project NextGen Agreement Leads To NIH Pick Bertagnolli Confirmation Hearing In October

Dose Optimization In Oncology Drug Combinations: “Dosing Toolkit” Is Next Step In “Project Optimus” To Prepare Sponsors For Filing And Avoid Review Delays

Real-World Views On RWE: RECOVER Trial On Long COVID Seen As US Answer To UK’s RECOVERY; Data Sources Are Ongoing Challenge To RWE Trial Interpretation

Prevision Policy Clips | Generic Drug Shortages Legislative Hearing In House Energy & Commerce Health Subcommittee Scheduled For September 14

FDA Human Factors Studies Guidance Finalized With New Name And Format; FDA Clarifies “Critical Tasks,” With Emphasis On Mis-Dosing, Time Sensitivity

Prevision Policy Clips | Merck Chronic Cough Drug Gefapixant Will Go To FDA’s Pulmonary-Allergy Drugs Panel November 17

CMS Resists Role As Rebate Monitor During IRA Transition: GAO Report Confirms Diabetes, Blood Thinners As Highly Rebated Classes In Part D

Prevision Policy Clips | FDA Sets Oct. 31 Date For Vertex/CRISPR “Exa-Cel” Committee

Prevision Policy Clips | CMS Chief Medical Officer Dora Hughes Will Oversee Alzheimer’s NCD Implementation Process

Prevision Policy Clips | FDA Releases Quality Management Maturity Program White Paper

Antibiotic Incentives Should Include Unbundling In Medicare, Paratek CEO Argues; BARDA Support For Novel Anthrax Treatment Could Be Model For Onshoring

Prevision Policy Clips | OTP Director Nicole Verdun Highlights Past Gene Therapy Experience, Importance Of Stakeholder Engagement

FDA Outlines “Deficiencies” In Cell/Gene Therapy INDs Amid Criticism Of Increase In Clinical Holds; OTP Director Verdun Delivers Remarks As New Super-Office Head

RWD/RWE “Considerations” Guidance: FDA Finalizes December 2021 Draft, Says RWE Considerations Will Apply Similarly To EUA Transition Products As Well As Traditionally Developed Products

Advisory Committee Tracker: Amgen’s Lumakras Poses Another AA Test For ODAC; FDA Will Use Committee For Intarcia Hearing – But Not Pepaxto

Prevision Policy Clips | FDA Final Guidance On Considerations For Use Of RWE To Support Regulatory Decisions Incorporates FDORA Provision

Price Negotiation Inaugural Class: J&J Has Three Products On The List; Four Diabetes Therapies Included; Will Generic/Biosimilar Launches Save Stelara, NovoLog or Farxiga?

Prevision Policy Clips | Price Negotiation “Top 10” List Unveiled: J&J Has Three Brands On The List