NCI NCORP Network Is Extending Oncology Research Into Community Setting, Sharpless Says: Potential Model For Other Therapeutic Classes

Prevision Policy Clips | New Molecular Entity Definition Changed In Legislation Sent To President Biden April 15

“ARPA-H” Translational Science Mission Questioned During House HHS Budget Hearing: Does New NIH Project Overlap With NCATS?

HHS Deputy, CMS Administrator Nominees Breeze Through Confirmation Hearing; Biden Drug Pricing Agenda Remains Undefined

Prevision Policy Clips | FDA “Current Thinking” On J&J COVID Vaccine: More Warnings In EUA Fact Sheet

FDA’s Woodcock Counters Speculation On “More Stringent” Standards; Calls For New Centers Of Excellence Should Go On Back Burner Due To Staff “Stress”

FDA Outlines Remote Inspection Program In New Guidance: Sponsors May Not Request Them And May Decline Them – If They Don’t Mind Approval Delays

Learning From COVID: OCE Outlines Research Agenda To Assess Impact Of Trial Modifications; Sponsors Asked To Flag All “Remote” Elements In Submissions

CellTrans’ Type 1 Diabetes Therapy Likely Needs CMC Work For Approval; FDA Sees Benefit But Asks Committee To Help Better Define Patient Population

Prevision Policy Clips | HHS Budget Hearing April 15 Will Feature Secretary Becerra

Medicaid Rebates To Enforce Accelerated Approval? New Idea For Congressional Debate; MedPAC Endorses Policies For Vaccines, Separately Payable Drugs

J&J COVID-19 Vaccine “Rare And Severe” Blood Clots Are Similar To Those Seen With AstraZeneca, FDA Says; Vaccination “Pause” Will Be Relatively Brief

Prevision Policy Clips | J&J COVID-19 Vaccine Subject Of Emergency ACIP Meeting April 14 After "Pause" In Vaccinations

Oncology Clinical Trial Eligibility Expansion A Focus For FDA, With More Guidance Coming; Sponsors Are Overcoming Initial Hesitation

CDER Leadership Change Is Official: Cavazzoni No Longer “Acting” As Director; Delicate Time For Drug Center Post-COVID

White House Keeps Drug Pricing Cards Close To The Vest In Budget Request; ARPA-H And "Cures" Act Prioritized; FDA Out Of Spotlight

Prevision Policy Clips | ARPA-H Gets High Profile But No Independence In Biden Budget: $6.5 Billion

CBO Report On Pharma R&D Paints Favorable Portrait Ahead Of Pricing Debate; Impact Of Adverse Policies On Innovation Is Still In The Eye Of The Beholder

Prevision Policy Clips | CBO Pharma R&D Profile Provides Timely Snapshot

CBO Public Option Report And Drug Prices: Negotiating Leverage Is King

Prevision Policy Clips | ICER To Review MyoKardia/Bristol Myers Squibb’s Mavacamten For Hypertrophic Cardiomyopathy

Prevision Policy Clips | FibroGen Roxadustat Advisory Committee Review Tentatively Set For July 15; Safety Data Snafu

180-Day Exclusivity For First Generics Could Be At Risk As Result Of Pandemic Inspection Challenges, FDA Warns In New Guidance

Prevision Policy Clips | RMAT Designation Requests Trending Up In 2021: New Data Posted

Advisory Committee Tracker: Accelerated Approval Review Will Highlight April Agenda; Application Reviews Slowly Returning To Calendar