ctDNA Meta-Analysis Can Provide Valuable Foundation For Use As Early Endpoint But Prospective Trials Still Preferred By FDA

Advisory Committee Tracker: Accelerated Approval In The Spotlight With Precedent-Setting Reviews Coming In Oncology, ALS And DMD

FDA Will Feel Effects Of User Fee Legislation Delays In “Early September” Commissioner Califf Warns; Hiring and Product Reviews Are Immediate Concerns

Prevision Policy Clips | CMS Seeks Ideas To Improve Medicare Advantage; Prior Authorization

Patient Experience Data In Label Depends On Endpoints Relevant To Patients – And MoA Of Therapy; Industry Says FDA Guidances Are Key Step For Using Social Media Data

“Project Site Selector”: FDA Oncology Office Launches Initiative To Increase US Enrollment In Clinical Trials

Do Or Die For Drug Pricing Reform: “Inflation Reduction Act” Emerges In Senate; Close Votes Ahead But Enactment Looks Likely

Prevision Policy Clips | PTO/FDA Coordination Bill Clears Committee By Voice Vote; Judiciary Chair And Lead Sponsor Durbin Has Covid

Prevision Policy Clips | FDA/PTO Collaboration: Senate Committee Will Consider Bill To Create “Inter-Agency Task Force”

Prevision Policy Clips | Another ALS Advisory Committee Coming In 2022: Biogen NDA For Tofersen

Oncology Patient-Reported Data: FDA Urges Sponsors To Collect PROs In Early Trials—Including Open-Label Trials

Prevision Policy Clips | Paxlovid For POTUS: Pfizer COVID Antiviral Has Another High Profile Patient

Gene/Cell Therapies Not Suited To “Real Time” Review, FDA Says In Draft Guidance On RTOR

Remote Regulatory Assessments: FDA Draft Guidance Keeps Bright Line Between RRAs and “Inspections” – But Agency Sounds Keen To Use RRAs Broadly Going Forward

Prevision Policy Clips | CBO Sees $1.3 Billion In Savings From Generic Provisions In Senate User Fee Bill

Prevision Policy Clips | Drug Pricing “Byrd Bath”: Sen. Wyden Confident Parliamentarian Will Sign Off

Drug/Device Combo Therapeutic Equivalence Decisions Will Be Made “Case-By-Case,” FDA Says In New ANDA Guidance/FAQ

FDA “Dose Banding” Draft Guidance Outlines Ways For Manufacturers To Repackage Drugs With Weight-Based Dosing; Implications for Reducing Drug Waste

Prevision Policy Clips | Oncology Accelerated Approvals Back At ODAC: Spectrum NDA For Poziotinib Will Be Reviewed September 22

FDA ALS Reviews: Congress Provides Another Push For Approvals; More Action, Less Plan?

Prevision Policy Clips | CDER Elevates Rx Misuse/Abuse Response To Full Time Deputy Level: Controlled Substances Program Director Marta Sokolowska

Prevision Policy Clips | CMS “Fully Expects” To Restore 340B Payment In Part B To ASP+6%; Nearly $2 Billion In Additional Drug Spending

Prevision Policy Clips | FDA Use Fee Stand-Off: Burr, Murray And House Push Separate Proposals

Prevision Policy Clips | Novartis/BeiGene PD1-Inhibitor Review Extended; Potential Case Study For Multi-Regional Trial

Califf’s Countdown To 2024: “Meta Issues” For FDA Include Better Evidence Generation, Countering Misinformation