CMS Coverage Policy Would Be Loosened Under Proposed Definition Of “Reasonable And Necessary”; Commercial Payors Could Drive Medicare Policy

ICER Update On Vertex CF Therapies: Same Themes, Even Better Product; Trikafta Seen As Highly Effective But Overpriced – And Broadly Covered

Prevision Policy Clips | FDA Will Schedule Additional Product-Specific COVID Vaccine Advisory Committees “As Appropriate”

ACIP Sees Health Care Personnel As First COVID Vaccine Recipients; Targeting HCPs Also Could Help Facilitate mRNA Handling Requirements

Advisory Committee Tracker: OxyContin Post-Market Review Tees Up Blockbuster Fall Panel Agenda For FDA After COVID Lull

Prevision Policy Clips | Trump Vaccine Promise Prompts More Headlines About Pressure On FDA – But Impact May Be The Opposite

GSK Trelegy Mortality Claim In COPD Patients At Risk Over Withdrawal Effect Of Inhaled Steroids; FDA Committee To Weigh Whether Survival Benefit Is Real

Prevision Policy Clips | COVID-19 Vaccines Advisory Committee Meeting Is October 22; No Applications Will Be Discussed

FDA CNS Metastases Draft Guidance: Endpoints And Labeling Should Not Be Exclusive To CNS Mets; Metastatic Disease Should Not Be Evaluated In Isolation

Prevision Policy Clips | CNS Metastases Drug Development Guidance Includes Study Design

Separating Gene Therapy “Wheat” From “Chaff”: CBER Facilitators Could Help Inexperienced Sponsors – And Free Up Time For More Mature Programs

Prevision Policy Clips | FDA Advisory Committee Discussion Of Reformulated Oxycontin Postmarketing Studies

FDA Uses Mayo Expanded Access As Keystone To EUA For COVID Plasma; Change From Expanded To Emergency Use Is Small; Impact of Politics On FDA Is Not

Prevision Policy Clips | IPI Executive Order Takes Effect At The Stroke Of Midnight

Global Regulatory Alignment Is Key To Public Confidence In COVID Vaccines, Biden Advisor Lurie Says; Collaboration On Safety Surveillance Would Help

Prevision Policy Clips | Alkermes Olanzapine/Samidorphan (ALKS-3831) Anti-Psychotic NDA Advisory Committee Review

Prevision Policy Clips | HHS Authorizes Pharmacists To Administer Routine Childhood Vaccines Across The US

FDA Q&A On Inspections In COVID: Agency Outlines Policy For Reviews That Require Inspections That Cannot Be Done

Is FDA Backing Off Accelerated Approval? Three Recent Cases Suggest Trend Worth Watching

Prevision Policy Clips | Two More CRLs Add To Recent Cluster Of FDA Rejections: Gilead And BioMarin

ClinicalTrials.Gov Compliance: Final FDA Guidance On Penalties Suggest Sponsors Will Have Ample Opportunity To Correct Errors Without Adverse Publicity

Acute Myeloid Leukemia FDA Guidance Is Complex: Patient Needs Cover Broad Spectrum And Treatment Objectives Are Changing

Prevision Policy Clips | HHS Good Guidance Practices Proposed Rule Defines "Significant" Guidance As Having $100 Mil. Impact, Separate FDA Reg Coming

Prevision Policy Clips | CMS Proposed Rule On “Medicare Coverage Of Innovative Technologies” Clears OMB

Prevision Policy Clips | FDA Finalizes Guidance On Civil Money Penalties Related To ClinicalTrials.gov Data