Prevision Policy Clips | Biosimilars Analytical Similarity Guidance Withdrawn, FDA Signals Lowering Bar For Lot-to-Lot Comparisons

Prevision Policy Clips | Keytruda, Tecentriq Use Restricted in Urothelial Cancer

Non-Traditional Antibiotics Preview: FDA Engaging Publicly in Early Stages With Phages, CRISPR, MABs, and Lysins; Payment Concerns Remain A Challenge

FDA Major Depressive Disorder Guidance Updated After 40 Years; Includes Considerations For Novel “Rapid-Acting” Antidepressants

HRSA Supports 340B Legislation To Clarify Entity Use Of Drug Savings, But Does Not Provide Detailed Suggestions; 60% Of Audited Entities Owed Repayments

Prevision Policy Clips | Senate Finance Drug Pricing Hearing June 26

BARDA Continues To Feature Antibiotic Resistance Projects At House Energy & Commerce Preparedness Hearing: $1 Billion Invested Over Eight Years

FDA Sees Recent Brand Approvals As Harder To Copy As Future Generics; FDA Plans To Start Generic Research Projects Earlier For Complex Products

Prevision Policy Clips | New Generic Drug Review Platform, Drug Label Updating Initiative Coming

Prevision Policy Clips | Senate HELP Health Care Cost Hearing June 26

Prevision Policy Clips | PTO Inter Partes Review Reform A Priority For Sen. Hatch

CREATES Act Clears Judiciary Committee And Heads To Senate Floor; CBO Score Comes In Higher At $3.8 Bil. In Savings

Prevision Policy Clips | Advair Generic from Mylan Likely Delayed Until 2019 Post-CRL

FDA HIV PrEP Draft Guidance Highlights Long-Acting Formulations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