FDA/EMA Launch Parallel Scientific Advice Program For Complex Generics; “Clearer Understanding” Of Regulatory Requirements Is Key Goal

Prevision Policy Clips | Will HR 3 Survive Mark-Up? Energy & Commerce Considers Drug Pricing Provisions Today

FDA/PTO Collaboration At Examiner Level May Be Long-Term Impact Of Biden Competition Plan To Address Drug Patents

Prevision Policy Clips | CMS Abandons Plan To Consider Commercial Market In Determining Part B Coverage Policies

Reconciliation Scorecard: House Democrats Start With $600 Billion-Plus Hit To Pharma; Negotiation Is Not The Only Provision To Watch

Prevision Policy Clips | FDA Vaccine Division Leaders Oppose Routine COVID Booster Dose At This Time, Lancet Article Indicates

Prevision Policy Clips | Federal Medicaid Program, HR3 Provisions Included In House Energy & Commerce Budget Reconciliation Package

Medicare Part B Demos Outlined By HHS In Low-Profile Drug Pricing Report; Biosimilars Are A Prominent Theme: Safe Terrain For Industry If Price Negotiation Push Fails?

Prevision Policy Clips | House Reconciliation Bill Mark-Ups Begin: Health Care Expansion On Ways & Means Agenda This Week

Mandatory Opioid Prescriber Education Gets Another Look; FDA Reconsiders Required Training As Part Of REMS

Prevision Policy Clips | FDA’s Cellular, Tissue and Gene Therapies Advisory Committee Recommended Against Setting A Strict Dosing Ceiling

FDA Launches Novel Excipient Review Pilot; Four New Inactive Ingredients Will Be Reviewed In First Two Years

Gene Therapy Dosing Caps Not Recommended By FDA Advisory Committee, But Standards Urged To Address “Empty” Capsids And Potential Toxicity

A User’s Guide To PDUFA VII: New Agreement Carries Forward PDUFA VI Priorities And Layers On New Projects; New Work Comes With Larger New Staff Support

FDA’s PDUFA VII “To-Do” List

Prevision Policy Clips | BioMarin Clinical Hold On PKU Gene Therapy Trial

Prevision Policy Clips | AAV Vector-Based Gene Therapy Dosing Restrictions Should Focus On Number Of "Empty" Capsids

Prevision Policy Clips | Oncopeptides Pepaxto (Melphalan Flufenamide) Marketing Status Will Be Reviewed By ODAC

Project Orbis Tracker: FDA Oncology Group International Parallel Review Program Exceeds Two Dozen Approvals; Could China Be Added?

Prevision Policy Clips | From “Dangling” To Full Approval: FDA Narrows Indication In Converting Accelerated Approval Of Merck’s Keytruda

COVID Vaccine Booster Data Will Be Discussed By ACIP In September, But Vote Will Await FDA Action; Is September 20 Deadline In Doubt?

COVID Vaccine Wrap-Up Reviews Will Be Led By CBER Director Marks Following Retirement Of Review Office Director Gruber, Deputy Krause

FDA Remote Inspections Guidance Part Of Push For “Alternative Tools” In PDUFA VII; CMC Pilot For Accelerated Products Starts In FY 2023

Prevision Policy Clips | Remote Trial Monitoring Adopted During COVID Can Be Continued After Restrictions Lift

Advisory Committee Tracker: FDA Continues To Hold Few Product Meetings; Takeda’s Antiviral Maribavir Set For Oct. 7; Reata Says Bardoxolone Will Get Dec. 8 Session