Prevision Policy Clips | "I'm Here To Keep The Chair Warm" For Janet Woodcock, CDER Acting Director Cavazzoni

HHS Tightens Oversight Of FDA Guidances In Waning Trump Days; Petition Process To Block New Guidance Included In Final Rule

Too Big To Test? FDA Workshop Will Seek Ideas To Determine Whether Opioid REMS Has An Impact – Or Whether Only Viable Test Is Overall Prescribing Patterns In US

CBER “Decision Tree” Will Determine Speed Of COVID-19 Vaccine Authorization Post Advisory Committee, Marks Says

Prevision Policy Clips | Pfizer/BioNTech COVID-19 Vaccine Overall Efficacy Appears Secure; Subpopulations Will Be Focus

Prevision Policy Clips | HHS To Exert More Oversight Of FDA Guidances

Medicare Part B 2021 Payment Rules Finalized: No Mention Of MFN; CMS Defends 340B Cuts, 505(b)(2) Policy But Backs Off From Proposed Changes

Time For Oncology Step Therapy? ICER Bladder Cancer Meeting Suggests Payers Are Ready – But NMIBC Therapies Unlikely To Be First Target

Prevision Policy Clips | CMS Drops Plans For Deeper 340B Cuts, Codification Of 505(b)(2) Policy

Prevision Policy Clips | UK Emergency Authorization For Pfizer/BioNTech COVID Vaccine

Digital Health Continues As A PDUFA VII Theme, RWE To Get Attention At Next Meeting; “Earlier Approvals” Proposal Advancing In GDUFA III

FDA Expanding Drug Development Tool Qualification Program With ISTAND Pilot; ClinROs, Artificial Intelligence-Based Algorithms Will Be Included In Approval Pathway

Prevision Policy Clips | Drug Development Tools: FDA Will Alert Sponsors To Changes To “Qualification” Status

Advisory Committee Tracker: COVID Candidate Vaccines Head To Committee; Milestone Moment In Pandemic – And For FDA

Prevision Policy Clips | Moderna Submitting EUA Request For COVID-19 Vaccine Candidate

HHS Rebate Rule Paradox: Azar Attacks Middlemen But Counts On Them To Get Discounts So Part D Net Prices Remain Stable

Prevision Policy Clips | Insulin, EpiPen 340B Pricing Final Rule Awaiting Clearance

Part B Target List: “Most Favored Nation” Rule Includes International Prices For Top 50 Drugs; Data Will Have Impact Even If Rule Is Blocked

Prevision Policy Clips | The Trump Pricing Lawsuits Begin: PhRMA And Allies Challenge Import Rule

Rolling Back The Regulatory Clock: HHS Ends Unapproved Drugs Initiative In Effort To Cut Off Re-Pricing Strategies

“Most Favored Nation” Rule: Political And Legal Challenges May Doom Proposal – But Threat To Part B Is More Sharply Drawn And Unlikely To Disappear

FDA Offers Either/Or Approach To Interchangeable Applications: Sponsors Can Apply For Both, Or Go For Interchangeable Only

Prevision Policy Clips | Regeneron Antibody Cocktail Casirivimab/Imdevimab Will Be Available to 300K Patients

BsUFA III: Sponsors Want More Clarity On Post-Market Application Timelines; Industry Wants More Meetings, Despite FDA’s Sense Of Burden

Prevision Policy Clips | Pfizer/BioNTech COVID Vaccine EUA Will Be Submitted November 20