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Legislation

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UK Reveals Plans For ‘Dynamic’ Post-Brexit Regulatory System

At the end of the Brexit transition period, the UK will be charting its own course through the often choppy seas of medicines regulation. While it plans to retain the existing EU rules that have been transposed into domestic legislation, it also wants the freedom to tailor its regulations in areas like clinical trials, advanced therapies and product labeling.

United Kingdom Regulation

Biopharma Needs A Deal On Drug Pricing As Shield Against Possible Democrat Wins – BIO’s Greenwood

Outgoing Biotechnology Innovation Organization CEO suggests consideration of price inflation caps instead of 'big discounts' in Medicare Part D and says that industry should fund a cap on beneficiary out-of-pocket costs in the program.

Pricing Debate Elections

Trump Administration Signals Deference To Congress On Drug Pricing Policy

In a marked departure from previous years, budget proposal offers few specifics on cost reductions, but the $135bn savings estimate is a tacit endorsement of the Grassley-Wyden bill in the Senate.

Pricing Debate Legislation

US FDA’s Human Drugs Program Suffers In Adjustment Of Agency Priorities

President Trump's budget request would boost compounding and vaccines by $5m, but human drugs program would lose $4.8m in training funds.

FDA Legislation

Expanded Access Advocates Seek Reimbursement Mandate, Manufacturer Incentives From Congress

Next round of biomedical innovation legislation provides opportunity to require insurance reimbursement of investigational drugs and related medical services, as well as new incentives for small biotech companies to offer expanded access programs, stakeholders say.

Legislation Reimbursement

Generic Association CEO Davis Jumps To Wholesalers Group

Association for Accessible Medicines’ interim leader is General Counsel Jeffrey Francer; Chip Davis’ four-and-half year tenure included a total rebrand of the association, a significant legislative victory with the CREATES act – and an abrupt departure for the Healthcare Distribution Alliance.

Biosimilars Generic Drugs
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