Prevision Policy Clips | FDA Non-Opioid Acute Pain Guidance Includes Discussion Of “Opioid-Sparing” Effects

FDA Pilot Program On Unannounced Foreign Inspections Gets Another Push From GAO

Antibody-Drug Conjugate Complexity And Narrow Therapeutic Window Addressed In FDA Draft Guidance On Pharmacology Considerations

FDA Sintilimab Review Completes Public Re-Set On China-Only Trials: Lilly/Innovent ORIENT-11 Is Positive Study, Agency Says, But Inadequate For US Approval Of PD1 Inhibitor

Prevision Policy Clips | ARPA-H House Hearing Will Go On Despite Resignation Of Biden Chief Science Advisor Eric Lander

FDA Sets 3 mmHg Threshold For Pressor Effect Studies Impacting All Chronic Use Drugs; Revised Draft Guidance Has More Precision In Advice To Sponsors – And Eliminates PRECISION Trial References

Dravet Syndrome Caregivers Say Seizure Control Is Top Treatment Priority – But Quality Of Life Improvement Is Major Treatment Goal

Prevision Policy Clips | FDA Nominee Califf Promises To Clean Up Accelerated Approval In 30 Days; Sen. Wyden Not Satisfied

China-Only Data’s Me-Too Problem: OCE’s Pazdur Says Single-Country Applications Fail To Address “Unmet Need” In The US

FDA Mandatory Recall Authority Passes House As Part Of “COMPETES Act” Along With $100 Million To Fund Advanced Manufacturing Centers; Will It Survive Senate Conference?

FDA Working On Transition Plan for COVID Products, Recognizing Public Health Emergency Will End; PDUFA Hearing Includes Focus On Pandemic Lessons Learned

Prevision Policy Clips | Another Pepaxto? TG Therapeutics Ukoniq Accelerated Approval Status Under Review After FDA Alert

PDUFA Renewal Kicks Off Well In House Hearing: Dems Support Rapid Reauthorization, Republicans Want To Talk Coverage – And Aduhelm

Prevision Policy Clips | Drug Supply Chain Security Act: FDA Proposed Rule Revises “Outdated And Conflicting” Requirements

Prevision Policy Clips | Cancer Moonshot II Launch Set: Pro-Innovation Themes, Broad But Vague Goals

Registries Have Inherent Advantages For Producing Real World Evidence, FDA Makes Clear In Description Of Recent Guidance

Second COVID Vaccine Approval is Step Toward BLAs Instead of EUAs; Moderna Awarded Priority Review Voucher With Spikevax Clearance

Advisory Committee Tracker: Gene Therapies Likely To Return To Advisory Committees In 2022 – But Dates Up In The Air

Prevision Policy Clips | Moderna's Spikevax BLA Approved, Granted Priority Review Voucher

Lilly’s Novel Mechanism Antidiabetic Tirzepatide May Face Challenge With Payors At Least Until Cardiovascular Outcomes Trial Is Done, ICER Discussion Indicates

CDER Guidance Agenda For 2022 Includes New Framework For Biomarker Qualification, Expansion of RWE Guidance Series

FDA “Orange Book” Report Shows Lack Of Consensus On Changes; REMS-Related And Digital Patents Are Focus Area For New Ideas

Prevision Policy Clips | Could Device User Fees Hold Up PDUFA VII? Congressional Health Leaders Send Letter To FDA

Keytruda Takes Top Spot In Medicare Part B Drug Spending With 2020 Now Released; Biosimilars, COVID Have Impact On Top 10 List

Prevision Policy Clips | User Fee Reauthorization Kick Off Hearing Set For Feb. 3: Pharmaceutical Programs