Long-Term Opioid Study: FDA AdCom Says Proposed PMR Design Is Feasible, But Unlikely To Provide Significant Info; Is There A Safe Next Step?

MedPAC Eyeing PBMs As Next Frontier In Part D Oversight; Finance Committee “Framework” Focuses On “De-Linking” PBM Payment From Drug Prices

Prevision Policy Clips | Novavax COVID Vaccine Update Process: “Technical Challenges” Will Be Focus Of FDA Workshop April 27

Prevision Policy Clips | Cell/Gene Therapy Clinical Holds: FDA Commissioner Califf Acknowledges “Issues”

COVID Vaccine “Simplification”: Original Formula No Longer Authorized; June AdCom Will Select Strain Likely To Launch Commercially – Will Single Booster Boost Uptake?

Innoviva/Entasis SUL-DUR AdCom Goes Smoothly; FDA Office Of Infectious Diseases Shows Finesse In Moving “Streamlined” Reviews Forward

Prevision Policy Clips | FDA External Affairs Interim Head Will Be Heidi Rebello

Prevision Policy Clips | FDA Moves To Bivalent-Only COVID Vaccine Model, Authorizes Second Bivalent Booster In Some Populations

Long Wait For Long-Term Opioid Trial: FDA Seeks Committee Support For Novel Withdrawal Design To Fulfill Decade-Old Post-Marking Requirement

Otsuka/Lundbeck’s Rexulti Clears FDA Committee For Alzheimer’s Agitation: Efficacy Is Small But Clear; Mortality Risk Is “Consistent” With Class Effect

Prevision Policy Clips | COVID Vaccine “Anticipated Regulatory Changes” Prompt ACIP Meeting On Short Notice

FDA Tries Again On Opioid Relabeling: Updated Indication, New Warning About Hyperalgesia Ordered Ahead of April 19 Advisory Committee Discussion Of Delayed Post-Marketing OIH Trial

Innoviva/Entasis SUL-DUR Advisory Committee Appears Set To Showcase “Streamlined” FDA Approach To Anti-Infective Development For Unmet Needs

Prevision Policy Clips | FDA Rare Disease Endpoint Advancement (RDEA) Pilot: June 7-8 Workshop

New Technology Add-On Payments: CMS Proposes Earlier Deadline For FDA Approval To Qualify In Future Years; 19 Drugs Under Consideration For NTAP Status In FY 2024

Part B Drug Pricing Reforms Endorsed By MedPAC: Is There Appetite For More Changes Amid IRA Implementation?

Prevision Policy Clips | Pragmatica-Lung Phase 3 Advanced NSCLC Survival Trial With Cyramza/Keytruda

FDA Guidance “Snapshots” Pilot Explained: CDER Describes Purpose Of Initiative, Patient-Directed Explanations Up Next

Otsuka/Lundbeck’s Rexulti In Alzheimer’s Agitation Benefit/Risk To Be Debated By FDA Advisory Committee: Can An Appropriate Population Be Identified?

Shortage Notification Guidance Updated: COVID-Era Message To Manufacturers To Err On The Side Of Informing FDA Will Continue Post-Pandemic

Prevision Policy Clips | Quantity Reporting: FDA Finalizes Exemption For Single-Use Gene/Cell Therapy Lots

Prevision Policy Clips | CMS Projects Novel Anti-Infectives Could Net $213 Mil. In Add-On Payments For FY 2024

Prevision Policy Clips | Sarepta DMD Gene Therapy Advisory Committee Set For May 12

Prevision Policy Clips | Makena And Generics Formally Withdrawn Immediately, FDA Commissioner Califf And Chief Scientist Bumpus

Accelerated Approval Planning For Rare Diseases: FDA “ARC” Initiative Aims To Encourage Early Discussions – Even At Pre-IND Phase