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

ODAC Delivers Favorable Efficacy Vote In Milestone Event For First-In-Class Cell Therapy In Spite Of Many Unknowns; Will FDA Be Moved To Approve?

Drug-Drug Interaction Draft Guidance For Therapeutic Proteins Stretches Into Other CBER Categories: Gene And Cellular Therapies

Prevision Policy Clips | NS Pharma’s Viltepso Is Third Exon-Skipping DMD Therapy Approved By FDA, And Second Targeting Exon-53

FDA Interest In “Stable” Disease During Antifungal Treatment Suggests Willingness To Change: Workshop During COVID Shows Engagement

Prevision Policy Clips | CBER Director Peter Marks Is Front-Page News

FDA Communication Get Strong Marks From Outside Report; Industry Still Sees Room For Improvement In Consistency Of Best Practices

COVID Vaccine Process – First Lessons: US Lost Time Signaling Interest To Sponsors; Continued Interest In Second, Third Generation Vaccines Critical

ODAC Will Tackle Quality And New Tech In Complex Virtual Review Of Mesoblast Novel Cell Therapy; Another Trial Appears Very Likely

Prevision Policy Clips | Male Breast Cancer Drug Development Guidance Finalized

Prevision Policy Clips | GSK Trelegy COPD Mortality Benefit Will Be Discussed By FDA Advisory Committee on August 31