Prevision Policy Clips | Acadia Nuplazid sNDA Gets Deficiency Notification From FDA As April 3 PDUFA Deadline Approaches

MedPAC Proposal To Streamline Rx “Pass Through” Payment Policy Is First Step Towards Balancing Innovation Incentives, Chair Says; Commission Wants Shingrix In Part B

COVID-19 Vaccine Supply Chains Provide Model For Restoring On-Shore Pharma Manufacturing; Parking-Lot-To-Production-Site Stories Show Feasibility

Prevision Policy Clips | Tecentriq Accelerated Approval Withdrawn As Part Of “Industry-Wide Review”

Prevision Policy Clips | FDA Allows Added Flexibility For Drug Manufacturers To Make Changes To Glass Stoppers And Vials

Prevision Policy Clips | FDA Foreign Inspection Hearing Postponed By Capitol Security Threat

Prevision Policy Clips | FDA Tamps Down ALS Treatment Prospects With Unusual Public Statement

NASEM Vial Wastage Report Recommends Fixed Dosage Fix – FDA Should Require Fixed Doses In Trials; CMS Urged To Move Away From ASP In Part B

NASEM Advanced Manufacturing Report Calls For “More Timely” CDER Evaluations Of New Tech; Direct Funding For FDA’s Emerging Tech Program

Prevision Policy Clips | AstraZeneca/FibroGen Roxadustat Delayed Again: FDA Will Convene Advisory Committee

J&J COVID-19 Single-Shot Vaccine Authorized By FDA: Ongoing Two-Dose Study, Lower Efficacy In Older Age Group With Comorbidities Are Issues To Watch

Prevision Policy Clips | FDA Waiting On AstraZeneca, Novavax COVID-19 Vaccine U.S. Trials To Read Out Before Accepting EUA Request

RWE Studies For Regulatory Use: Sentinel May Lead On Development Of Outcome Algorithms Across Databases

Advisory Committee Tracker: Pfizer/Lilly Anti-NGF Therapy Tanezumab Will Test FDA’s Flexibility For Non-Opioid Pain Drugs

Prevision Policy Clips | Senate HELP Hearing on COVID Response Coming "Soon"

COVID-19 Observational Lessons: FDA/Duke Workshop Spotlights Tocilizumab Success, But Problems Gaining Acceptance

FDA Developing Guidances On RWE Studies For Regulatory Decisions; Duke/FDA Workshop Highlights Lessons Learned From Clinical Trial Replication Project

HHS Nominee Expands On Drug Pricing: Pledges “Bipartisan” Focus On Issue; Defends “March In” Letter On Remdesivir, But Stresses Extraordinary Circumstances

Prevision Policy Clips | Pharmaceutical Supply Chain Review By HHS: 100 Days To Generate Policy Recommendations

J&J One-Shot COVID-19 Vaccine: FDA Sees Lower Efficacy Balanced By Better Safety Profile, Sustained Efficacy Against South African Variant

Prevision Policy Clips | White House Will Order Review of Pharmaceutical Supply Chain

HHS Nominee Pledges To Move “Swiftly” On Drug Pricing, But No Specifics; PBMs Must Be “Kept On Their Toes”

Prevision Policy Clips | Medicaid Rebate Provision Will Stay In Senate COVID Relief Bill, Finance Chair

COVID-19 MAb Development Guidance Calls For Cooperation Among Manufacturers; FDA Suggests Surrogate Endpoints Possible For Variants

FDA Sets 10% Non-Inferiority Margins For Modified Coronavirus Vaccines As Agency Gets Ready For Variants; CBER’s Marks Details Trial Size, Length