Prevision Policy Clips | RMAT Designations: Biologics Center Continuing To Approve One-Third Of Submissions

Emergent/Janssen Awaiting FDA Response To Proposed Bayview Process Changes; Janssen Vaccine Production Could Start Within Days Of Acceptance

Ex-Commissioners See Mostly Positives In Public View Of FDA After COVID; Focus Should Be On Quality Of Guidance, Not Faster Reviews, McClellan Suggests

Prevision Policy Clips | FDA Confirms FibroGen/AstraZeneca Roxadustat Advisory Committee Meeting For July 15

Which CEO Is Next? House Drug Pricing Hearing Features Bipartisan Attacks On Industry Business Practices With AbbVie As The Target

Prevision Policy Clips | Oncology Center of Excellence Seeking Outside, Crowdsourcing Ideas For Pooled Analyses

Woodcock Reaffirms Top-Level FDA Commitment To Tech Modernization; Agency Is “Laser-Focused” To Updates, She Tells FDLI

Manufacturing Q&A Guidance Clarifies Actions FDA Will Take When Facilities Cannot Be Inspected During COVID-19

OCE’s Project Patient Voice May Include Pediatrics As New PRO Measurement Tool Sees Trial Uptake

Master Protocol Trials For COVID Therapies: “High Degree” Of Early Planning Urged; FDA Lookback On Adapting Approach To Evolving Crisis

Prevision Policy Clips | HHS Orders Six Manufacturers To Drop Conditions On 340B Sales To Contract Pharmacies

Prevision Policy Clips | CMS May Pursue Separate Rule On "Reasonable And Necessary" Definition

FDA Oncology Center Working On Standardization Of External Control Data Using RWE; NCI Pediatric Initiative Could Provide “Stimulus” For Similar Adult Effort

The HR3 Long Game: Excise Tax Enforcement Mechanism Could Survive Legal Challenge Under ACA Precedent—Though Supreme Court Has Changed

Prevision Policy Clips | ALS Listening Session For FDA Set For “Later This Month”

Prevision Policy Clips | ODAC Schedules Review Of Incyte’s Retifanlimab June 24

Pfizer COVID-19 Vaccine Easily Clears ACIP For Use In Adolescents, But Committee Skeptical Of CDC Policy To Allow Co-Administration With Other Vaccines

HHS Secretary Sounds Collaborative On Drug Pricing, Though Rhetorical Support For Negotiation Remains; Becerra Hears Bipartisan Praise For FDA’s Woodcock

Prevision Policy Clips | HHS Deputy Palm Confirmed By Senate; CMS Nominee Still Pending

COVID Vaccine Booster Strategy: Biden Administration Planning Free Doses For 2022 Using Existing Funds; Next Steps Will Depend On Congress (And The Virus)

Prevision Policy Clips | Pfizer/BioNTech COVID-19 Vaccine EUA For Adolescents Was “Relatively Straightforward” Decision

Prevision Policy Clips | Senate HELP COVID Hearing May 11: FDA’s Marks May Have News

ChemoCentryx’ Avacopan: Split Committee Leaves FDA Flexibility To Demand A New Trial Prior To Approval For AAV – Or Grant A Narrow Label In Already Rare Condition

Prevision Policy Clips | ACIP To Consider Pfizer/BioNTech COVID Vaccine In 12-15 Year-Olds At May 12 Meeting

Rare Disease Drugs Would Not Be Affected By HR 3 Price Negotiations, House E&C Hearing Told; “Guardrails” In Place To Protect Small-Market Products