Prevision Policy Clips | FDA Guidance On Studying Multiple Versions Of Gene Therapy In Single Trial

FDA NASH Guidance Revisions Coming Soon: Non-Invasive Biomarkers Still Need More Work, New Division Leadership Says; Digital Read Of Liver Biopsy OK

Prevision Policy Clips | FDA Should Consider Using “Alternative Inspection Tools” To Combat Potential Manufacturing Inspection Backlog, GAO Recommends

Biden’s OMB: No Internal Backstop For Most Aggressive Drug Pricing Administrative Actions; Look For Part B Drug Payment Model Redux

COVID-19 Variant “Playbook” Under Development By FDA: Small Vaccine Trials, Streamlined Authorization Expected For Follow-Up Shots, CBER’s Marks Says

Advisory Committee Tracker: Empty Calendar Likely To Fill Up As 2021 Progresses

Prevision Policy Clips | Rebate Rule Delayed To 2023 Following Court Decision In PCMA Case

Prevision Policy Clips | FDA, Biogen Buy Time To Weigh Aducanumab Verdict: Three Month Extension

Early Approvals At FDA: 34% Of NMEs Beat User Fee Deadlines By More Than Two Weeks in 2020; Veklury, Oncology Products Lead Hyper-Fast Approvals

Prevision Policy Clips | Will Opioids Be Woodcock’s Undoing? Public Citizen, Other Advocates Urge HHS Nominee Becerra To Look Elsewhere For FDA

BsUFA III Negotiations Will Be Informed By ERG Interim Report On Review Program Efficiency; Information Requests Are One Area Of Improvement

Acting FDA Commissioner Woodcock Proposes “National Clinical Trial Capacity Stockpile” Using Community Sites; Academic Centers Are “Not The Answer”

Prevision Policy Clips | CDER’s Cavazzoni Cautions That FDA May Miss More User Fee Deadlines

FDA Says No To Pre-Approval Inspection Waivers In PDUFA VII, But More Interested In Ideas To Schedule Pre-Approval Inspections For Biologics

FDA Guidance Agenda Includes Clarifying Single Trial As “Substantial Evidence”; Antisense Oligonucleotides, RWE, GI Diseases Are Other Areas Of Focus

Prevision Policy Clips | Iterum Sulopenem FDA Advisory Committee Meeting Expected For Oral UTI Antibiotic

Prevision Policy Clips | PDUFA VII Update: CBER Provides Resource Requests For Cell/Gene Therapy Products

Prevision Policy Clips | Biden Vaccine Plan Features More Coordination On COVID-19 Antivirals, Medicaid Assistance On Vaccines

HHS In Transition: Woodcock (FDA), Richter (CMS) and Cochran (HHS) May Be Acting Leaders For Some Time

Prevision Policy Clips | Woodcock As Acting FDA Commissioner Will Continue To Recuse Herself From COVID Therapeutic

Gene Therapy Production Precautions During COVID Include Close Attention To Cells Used In Vector Production; FDA Expects Risk Assessment Statement

Prevision Policy Clips | FDA Interested In Using Sentinel To Study Pregnancy Safety Outcomes Under PDUFA VII

The Longest-Eleventh Hour: Late Regulatory Flurry Creates Long To-Do List For Biden HHS

CMS Coverage Policy Would Add Commercial Payer Considerations For Drugs In “Reasonable And Necessary” Final Rule; Will Biden Administration Abide?

Prevision Policy Clips | HHS Deputy Secretary Will Be Andrea Palm; Current Wisconsin Health Secretary