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

FDA Inspection Backlog: One-Quarter Of Domestic Visits Can Be Cleared In FY 2021; About 50 NDAs Have Been Delayed Solely Due To COVID Pandemic

FDA Research On “Sameness” For Oligonucleotide Products Is Ongoing; Drug-Device Combos Are Priority For Product-Specific Guidances

Prevision Policy Clips | MCIT Final Rule Defining “Reasonable And Necessary” For Medicare Coverage Will Move Forward

House Pushing HR 3 Drug Pricing Bill (Again) With Dual Hearings; Everyone Agrees There’s A Problem – But Not On The Solution

Biden Administration Backs IP Waiver For COVID Vaccines: One Off Event Or Sign Of Things To Come?