FDA After COVID: CDER’s Key Learnings Remain De-Centralized Trials, Remote Inspections, And Supply Chain Oversight; EUA Transition Appears Manageable On New Drug Side

Prevision Policy Clips | FDA Labeling Webpages For Industry Include Patient Labeling Resources For Prescription Drugs

Novavax COVID Vaccine Appears To Meet EUA Standards Set By FDA In 2020; Will Advisory Committee Support Applying That Model In 2022?

Prevision Policy Clips | Amylyx ALS Drug AMX0035 Receives Three-Month User Fee Deadline Extension To September 29

Prevision Policy Clips | FDA User Fee Reauthorization Bill Set For Senate Mark-Up June 8

Advisory Committee Tracker: A Busy June For CBER Committees; Y-mAbs, Reata Expect Reviews For Their Newly Filed Applications Later This Year

Prevision Policy Clips | FTC/DoJ Workshop On Pharmaceutical Industry Mergers And Antitrust Enforcement Set For June 14-15

Prevision Policy Clips | Drug Pricing Bubbling Back Up As Manchin, Schumer Talks Get More Serious

Senate User Fee Bill Directs FDA To Set Up Internal “Accelerated Approval Council”; Other AA Provisions Largely Harmonize With House Approach

CDER/CBER Are Aligned On ARC Rare Disease Initiative; Surrogate Endpoint/Biomarker Work Should Start Early, Agency Officials Say At FDA/Duke Margolis Workshop

Prevision Policy Clips | Novavax COVID Vaccine EUA Request Set For June 7 Advisory Committee Review

FDA Quality Management Maturity Initiative Aims To Be “Proactive And Rewarding” For Sponsors; “Encourage More, Punish Less” Is OPQ Theme

Prevision Policy Clips | ARPA-H Staffing Begins With Ex-DARPA Program Manager Adam Russell

FDA/Industry Quality Management Maturity Pilot Sets Outline For Viable Program; Details To Be Filled In – Including FDA Role In QMM Assessments

Rx Import Q&A Guidance Reiterates Plan Parameters Outlined In Final Rule; FDA Showing Step Forward Without Opening Border?

Prevision Policy Clips | FDA’s Califf In Crisis Management Mode: Infant Formula Shortage

Prevision Policy Clips | Spikevax, Comirnaty Pediatric COVID Vaccine Panel Reviews Set For June 14-15

RWE Effort Pointing Toward Point-Of-Care Trials: FDA Interested In Diversity And Generalizability; Duke-Margolis, CTTI Stakeholders Discuss Advantages

Oligonucleotides: INDs Trending Up With Oncology/Hematology Accounting For Highest Percentage Of Activity Tracked By FDA

Prevision Policy Clips | FDA Updating Antibacterial “Unmet Need” Guidance

Single-Arm Rare Disease Trials “Work Only When Very Lucky”: FDA Maintains Strong Counsel To Rare Drug Sponsors To Randomize From First Patient

Prevision Policy Clips | FDA Unannounced Inspections Have Commenced In India, “Hundreds” Of Visits Expected

FDA “Enterprise Transformation” Starts With Inspections; Deputy Woodcock’s Latest (And Last?) Legacy Project

Avoiding Shortages: FDA Risk Management Plan Guidance For Manufacturers Follows ICH Template; Appendix Describes Specific Risk Factors

VALID Inclusion In Senate User Fee Bill Is Likely Best Chance For Passage Of LDT Oversight; Tiered Regulatory System Revives “Moderate-Risk” Test Category