Gene Therapies For Rare Diseases: Strong Natural History Studies And N-Of-Some Trials Headline Meeting; FDA Commissioner Hahn Makes A Debut

Prevision Policy Clips | Gilead Remdesivir Randomized Trial Results Expected “Reasonably Soon”

Drug Pricing Takes Back Seat To Coronavirus In Latest HHS Budget Hearing; Debate On Overseas API, Shortages Could Have Longer-Term Impact on Pharma

Prevision Policy Clips | ODAC Reviews Will Test Accelerated Approval, Show Expectations For PFS v. Survival In First Line Lung Cancer

Steba Takes Tookad To FDA Committee For Early Prostate Cancer: Novel “Prevent/Delay” Endpoint Will Test Accelerated Approval Parameters

Lilly Cyramza First-Line Lung Cancer Claim: FDA Review Suggests Survival Benefit Needed For Approval – But Strong PFS May Work One Last Time

Hahn’s FDA Prepares For “Deeming Day”: NDA-BLA Transition Marks Early Milestone In New Commissioner’s Tenure

Prevision Policy Clips | FDA Rare Disease Division Leadership Still Unsettled Following Departure Of Dragos Roman

Prevision Policy Clips | FDA “Class Of 2019” NME Profile: Seven Products Were Approved Based On US-Only Trials

FDA’s “Technology Modernization Action Plan” Moves To First Tangible Projects; Streamlined IND Safety Reporting Is An Early “Living Example”

FDA Guide To Pharmacogenomic Tests Includes Three “Unapproved” Drug Claims; Effort To Guide Consumers Underscores Gaps In Regulatory Framework

FDA Protein Definition Retains “Bright Line” At 40 Amino Acids; New Rule Takes Effect In Time For BLA Deeming Day

Prevision Policy Clips | FDA Finalizes New Definition Of Biologics: “Bright Line” At 40 Amino Acids

HHS Inspector General Studying Use Of “High-Expenditure” Medicare Drugs For Orphan Indications; Report Due In 2021

Prevision Policy Clips | GSK’s Trelegy Survival Benefit Claim Will Be Reviewed By FDA Advisory Committee April 21

Prevision Policy Clips | CBER CAR-T and Genome Editing Guidances Among Next Projects

Prevision Policy Clips | Belviq Obesity Drug To Be Withdrawn, Just The Beginning For FDA?

WAC Inflation Penalty Has Strong Support From HHS Secretary; Not “Price Control,” Would Improve Incentives In Supply Chain, Azar Says

NIH Has Big Objectives In Gene Therapy Production, But Short-Term Focus Likely On Incremental Funding To Expand AAV Facilities

Prevision Policy Clips | OND Reorg: Still Waiting For Phase IV

CSI-FDA? “Controlled Substances Initiatives” Team Will Launch Opioid Data Warehouse in March; Agency Developing Cocaine/Methamphetamine Use Disorder Guidance

Prevision Policy Clips | CMS Plans To Streamline Prior Authorization Process

Prevision Policy Clips | HDA Names Chip Davis New CEO; AAM Starts Search Amid “Wholesale” Changes To DC Association Leadership

Flu Vaccine Upgrade Would Be Supported By Enhanced Medicare Payments Under Trump HHS Proposal

HHS 2021 Budget Request Drops Specifics On Drug Pricing In Favor Of General Call For Legislation; FDA Does Well Once Again Relative To Other Agencies