FDA Oncology Center “Project Catalyst” Debuts: Drug Regulation 101 Event Showcases Collaborative FDA – And Its Limits

Prevision Policy Clips | Drug Pricing Part Of Second Infrastructure Plan, White House Chief Of Staff Ron Klain Confirms

Prevision Policy Clips | Biotech R&D, Pandemic Preparedness Among Items To Be Supported In Biden Jobs Bill

Simplifying Randomized Trials: RECOVERY Shows Value Of Pragmatic Studies; Mars-Shot Approach Building On Existing Trial Networks Could Speed US Toward Similar Effort

Prevision Policy Clips | Merck Will Discuss “Next Steps” With FDA After CRL For Keytruda

Prevision Policy Clips | FDA Commissioner Search: White House Press Corps Takes Note

HARPA Health Research Projects Agency Anointment Likely In Biden Budget; New Agency Would Bring DARPA Culture To Projects Stalled By Market Failures

Prevision Policy Clips | GlaxoSmithKline/Vir Plan To File For Emergency Use Authorization For “Dual-Action” Coronavirus Monoclonal Antibody

Pfizer/Lilly’s Tanezumab Rejected By FDA Advisory Committee Due To Joint Risk: Is There A Revamped REMS That Might Save The BLA – And The Class?

Prevision Policy Clips | FDA Arthritis Advisory Committee Will Hold May 6 Meeting For ChemoCentryx’ Avacopan

International Reference Pricing, Medicare Negotiation Are Themes At Sanders Drug Pricing Hearing; Pelosi Says HR3 Should Be In Infrastructure Package

Prevision Policy Clips | House Speaker Pelosi Says “Aspects” Of HR3 Drug Pricing Bill Could Be In Infrastructure Package

FDA Principal Deputy Abernethy’s Departure Leaves Need For Conduit To Digital Community; Exit Adds To Era Of Change

Prevision Policy Clips | AstraZeneca Review Of COVID Vaccine Primary Efficacy Analysis Underway Following DSMB Concerns

Pfizer/Lilly Tanezumab Prospects In Osteoarthritis Shaky Ahead Of Committee Review; FDA Appears Unconvinced Proposed REMS Can Address Joint Risk

Prevision Policy Clips | AstraZeneca Plans FDA EUA Submission “In The Coming Weeks” For Coronavirus Vaccine

FDA Rare Disease Center of Excellence Proposed In New Bill (STAT Act); Provisions Include FDA-Led Payor Feedback Program For Drug Developers

Prevision Policy Clips | Regulatory “SUNSET” Rule Formally Delayed By HHS

Long-Term COVID Response Is Key Theme At Senate Health Hearing: Outlook For Vaccine Boosters And Pricing, Need For Therapeutics – And Return Of David Kessler

RWE Trials Could Be Used In Community Setting, FDA's Woodcock Says; Burden Of COVID-19 On Product Reviews Has Been “Tremendous”

Prevision Policy Clips | HHS Secretary Nominee Becerra Set For Confirmation Vote Today; Will Woodcock Nomination Follow?

FDA Takes Backseat In COVID Response Hearing: CBER Director Marks Faces Few Questions; Says US Vaccine Supply May Support Boosters

Ex-FDA Commissioners Call For More Active Government Role In Emergency Drug Development: Directing Patients To Preferred Projects

Fast-Acting Antidepressants Will Benefit From New Patient-Reported Outcome Tools; FDA’s Farchione Explains Spravato, Zulresso Reviews, Sees Exciting Time In Psychiatric Drug Development

Prevision Policy Clips | “Protected Classes” Win Again: CMS Revises Part D “Payment Modernization Model”