CDER Leadership Shuffle: Acting Director Will Be Cavazzoni

Democratic Health Care Platform 2020: “Health Security” – Not Medicare For All – Likely Focus

Prevision Policy Clips | PDUFA VII Kick-Off Meeting Set For July 23; “Virtual Meeting”

COVID-19 Clinical Trial Disruption: Survey Shows High Impact On Derm, Psych Studies, Least In Oncology; CTTI Webinar Highlights Virtual Benefits

Prevision Policy Clips | AstraZeneca/Oxford COVID-19 Vaccine: First UK Deliveries In September, US In October

Prevision Policy Clips | CDER, CBER Deputies Will Backstop COVID-19 Reviews Following “Recusals”

OCE Flexibility On COVID Disruptions: FDA's Pazdur Offers Optimistic Outlook For Rebound In Clinical Development

Prevision Policy Clips | Onshoring Essential Drugs For COVID-19: Civica Rx Included In BARDA Contract To Manufacture

“Operation Warp Speed” Sets FDA Officials As COVID-19 Development Leads; Greater Federal Control Compared To Other Partnerships

COVID-19 Vaccines: “Stepwise” Emergence Likely Despite “Operation Warp Speed” Rhetoric; Priority Groups Likely To Differ From H1N1 Pandemic

Prevision Policy Clips | HHS “Operation Warp Speed” Includes FDA’s Woodcock And Marks In Key Roles

HEROES Act Supply Chain, Manufacturing Provisions Worth Watching As Debate On Next COVID-19 Response Legislation Moves Forward

Prevision Policy Clips | FDA’s Woodcock Draws Praise In Politically Perilous Setting: Ousted BARDA Head Richard Bright

COVID-Affected Trials: Industry White Paper Coming Soon on Statistical Recommendations For Salvaging Studies Amid Pandemic

NTAP Class Of 2021: Six Antibiotics In Line For Add-On Under Streamlined Pathway; Six “Regular” Drugs Will Have to Convince CMS

Accelerating COVID-19 Vaccines: Pre-BLA “White Space” Could Be Good Time For EUA, CBER Director Says; Too Many Chefs Overseeing Federal Effort?

Prevision Policy Clips | Ex-GSK Vaccine Head Slaoui Floated As Lead For “Operation Warp Speed”

Prevision Policy Clips | Intercept May Be First “Virtual” Advisory Committee: NASH Indication Review June 9

Senate HELP Hearing On COVID-19: FDA Commissioner Hahn Avoids Hot Seat As Focus Turns To States’ Ability To Safely Reopen

Antibiotic Pass-Through Payment Would Be Faster Under CMS Proposal; CAR-Ts Headed For Separate Payment In Medicare Inpatient Setting

Infected Trials III: FDA Wants Updated Timelines For Post-Marketing Requirements ASAP; Compliance Implications May Not Be Clear Until Original Deadline Arrives

FDA COVID-19 Treatment Guidance: Pre-IND Is Starting Point, Placebo-Controlled Studies With Clinical Outcomes Is End; Platform Trials “May Be Appropriate,” But No Specific Advice

FDA Manufacturing Inspections Update: “Case-By-Case” Approach Continues Until On-Site Visits Can Resume Under “Phased Approach”

Prevision Policy Clips | FDA COVID-19 Updates Ahead Of Senate Hearing

Generic Drug Studies For ANDA Registration Facing COVID-19 Concerns: Generic Industry Hopes FDA Will Adopt More Flexibility In Response – And Perhaps Maintain That Approach Post-COVID

Loading More