FDA HIV PrEP Draft Guidance Highlights Long-Acting Formulations

Patient-Focused Drug Development Guidance Roll Out Begins: FDA Tests New Tone In Draft On Sampling And Data Collection

FDA LPAD Guidance Stresses Correct Labeling; Sponsors Should Tell FDA Early, Not Turn To Pathway To Salvage Problem Programs

Prevision Policy Clips | Opioid Bills Reported Out of Senate Finance; Patient Advocacy Transparency Amendment Not Included

Part B Negotiation Demo Coming, HHS Secretary Azar Tells Senate HELP Committee; Finance Committee Also To Hold Drug Pricing Hearing

Sleep Apnea Patient-Focused Meeting: Device-Centered Field Includes FDA Drug Center Participation

FDA Communication Policy: Final Guidances Maintain “Consistent With Label” Formula; “Off-Label” Explicitly Permitted In Payor Talks, Otherwise Get Used To “CFL”

Prevision Policy Clips | FDA Finalizes Guidances On Payor Communications, Broader “On-Label” Definition

CBO Score Of Opioid Response Bills: CREATES Could Work As Pay-For – With Room For More Ride-Along Bills

Prevision Policy Clips | Senate Finance to Markup Opioid Package June 12

Prevision Policy Clips | CREATES Act Mark-Up Held Over Until “Next Week”

PAHPA House Draft Headed for Introduction Later This Month; PRVs, Antibiotics Incentives Highlighted During Exchange With FDA’s Abram

Prevision Policy Clips | Ex-FDAer Lisa Lavange Takes on Trump

OND Reorg First Impressions: Oncology Still First Among Equals, Big Changes For Neurology, Biosimilars

Prevision Policy Clips | HHS Proposing Working Group On “Investment and Innovation”

REMS “Abuse” Bill Moving As Part Of Opioid Response: Senate Judiciary Committee Sets June 7 Mark-Up

FDA Commissioner’s Office Reorganization Will Precede OND Revamp; Goal Will Be Stability In Political Transition

Prevision Policy Clips | Neulasta Biosimilar Approved Without Advisory Committee

OIG Part D Brand Expenditure Review Indicates That Giving Plans More Tools Against Non-Rebated Drugs Could Be Quite Effective

Prevision Policy Clips | Office of New Drugs Reform Proposal Unveiled: 30 Review Divisions

FDA Looking To Standardize Cell-Based Manufacturing Processes, Gottlieb Says; “Clear Requirements” Could Expand Opportunities

FDA Oncology Pilot Programs Will Speed Review Of Efficacy Supplements; Expansion Outside Cancer A Longer-Term Possibility

Adolescents In Cancer Trials: FDA Guidance Urges Simultaneous Enrollment With Adults, Makes Broad Dosing Recommendations

Advisory Committee Tracker: FDA Confirms Remoxy Return Visit To Committee; Opioids Still Dominating Panel Topics

Prevision Policy Clips | Right to Try Sponsor Says Law Meant to “Diminish” FDA’s Power