Industry “Tentatively” Agrees To Increase Foreign Facility Fee Differential In GDUFA Negotiations; Program Fee Restructuring Is Key Area Of Disagreement

Most Favored Nation Codification Bill Would Give White House Leverage To Force Pricing “Deals” With All Manufacturers; Enactment Unlikely

Prevision Policy Clips | CBER Clarifies Clinical Hold-Related Policies For RMAT Designated Products

“America First” Proposals Still In Play By FDA With A Concession Under PDUFA VIII Negotiations; CMC Readiness Pilot Will End

ICER Impressed By Clinical Potential Of IgAN New B-cell Therapies, Sees Little Value At $170,000-$293,000 Annual Prices; Durability, Length Of Use Are Uncertain

Prevision Policy Clips | IRB Reform: “Maybe They Need To Be Paid” FDA Commissioner Makary Says

New Normal? VRBPAC Unanimously Supports Trivalent Flu Vaccines In Straightforward Meeting; OVRR’s Kaslow Says Agency Listening To Committee And Public Input

Prevision Policy Clips | All Drug Manufacturers Of Selected Drugs For Third Round Of Medicare Price Negotiations "Have Chosen To Participate"

Prevision Policy Clips | FDA Will Not Post CNPV Approval Documents For sNDAs Recently Cleared By Agency

Prevision Policy Clips | FAERS + VAERS = AEMS: FDA Launches Unified Adverse Event Report Platform

Prevision Policy Clips | Leucovorin Approval For CFD-FOLR1: Milestone For Real World Evidence, But Not Autism?

Prevision Policy Clips | No Sign Of FDA Vaccine Policy Reset In VRBPAC Briefing Documents

Crossing (Off) The Bridge: FDA Drops Requirement For “Bridging Studies” For Biosimilar Sponsors Using Non-US Comparators

Medicare Part D GLP-1 Model Sets BMI Bar At 35 For Coverage; Program Will Only Launch In 2027 With High Plan Participation (80% Of Covered Lives), CMS Says

Prasad’s Legacy: Politicized Center Directors; Other Initiatives May Fade Away – Though They Will Have Ripple Effects; CBER Will Have Fifth Director Of Trump Administration

Prevision Policy Clips | CBER’s Prasad Will Leave FDA In April

Avoiding A Warning Letter: FDA Draft Guidance Outlines Best Practices For Responding to Form 483 Inspection Reports; Firms Should Determine If Observations Affect Other Drugs, Facilities

FDA Backs Off Of “America First” User Fee Proposals In GDUFA Negotiations, But Formalization Of ANDA Priority Review Pilot Is Likely To Go Forward

Precision Psychiatry: Biomarker-Based Approaches To Mental Health Drug Development Are “Enormous Opportunity” But A Long Way Off, FDA Official Tells NASEM

PDUFA VIII Negotiations Show Progress On Patient Data Proposal; “America First” Proposals Still Alive After “Impasse”?

Prevision Policy Clips | ODAC Is Back: Two AstraZeneca Applications Set For Review April 30, Including Potential ctDNA Milestone

Prevision Policy Clips | FDA Chief Operating Officer Transition: Deputy Keller Will Succeed Butler

“Three-Year Exclusivity” Guidance Details FDA’s Thinking Behind Hatch/Waxman Supplemental Exclusivity Decisions; Separate Cohorts In Same Trial Can Qualify For Separate Exclusivity, FDA Says

ICH Postmarket Safety RWE Study Guidance Includes Focus On Data Considerations, Redesigns Conceptual Framework For Study Design Process

12-Digit NDC Rule Finalized By FDA; Manufacturers Have Seven Years Before Effective Date, With Three-Year Transition Before Enforcement