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Policy & Regulation

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Sharpless Calls For A Nimble, Flexible, More Efficient US FDA

In his first speech to an outside group, Sharpless strikes a collaborative tone, saying he expects to listen to the advice of the FDA bar, as well as his own experts.
FDA Leadership Regulation
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Regulation

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Latest From Regulation

US FDA IT Modernization Plan Will Lay Groundwork For Real-Time Data Submissions

Principal deputy commissioner Amy Abernethy cites IND safety reporting and oncology review pilot program as areas that would benefit from enabling receipt of sponsor data in real time; plan describes near-term strategy for modernizing agency’s technical infrastructure, developing technology tools around regulatory ‘use cases’ and improving collaborations with data and tech companies.

Artificial Intelligence Cybersecurity

Keeping Track: A Duo Of RTOR Approvals, Thumbs Up For First Oral GLP-1 Treatment, And First Ebola Vaccine Nears US Market

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Pink Sheet Podcast: US FDA Launches Project Orbis And The Rare Disease Cures Accelerator, Looks For Abuse-Deterrent CNS Drugs

Pink Sheet reporters discuss the US FDA's work with other countries to review and approval of cancer therapies at the same time, a new database for rare disease clinical trial and natural history data, and the agency's exploration of abuse-deterrent CNS stimulants.

Drug Review Rare Diseases

Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline

Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.

Biologics Legislation

EMA OKs Seven New Drugs But Delivers Another Blow To Emmaus

Seven new drugs have this week moved closer to gaining EU approval following positive recommendations from the European Medicines Agency, but Emmaus’ glutamine product has fared less well and the company is considering another route for getting the drug to sickle cell disease patients in Europe

Europe Drug Review

Longer Medicine Supply Delays Expected In No-Deal Brexit

Delays in the delivery of medicines with short lead times will be longer than originally expected in the event of a no-deal Brexit, UK health care providers have been warned.

United Kingdom Brexit
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Policy

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Latest From Policy

House Democrats Launch Price Negotiation Push: Extreme Plan Assures Strong Opposition

Pelosi is moving forward with a draconian plan to limit US prices to an international benchmark. For now, the “bill” is a three-page outline subject to considerable legislative drafting – and so extreme as to rule out bipartisan compromise for the time being.

Pricing Debate Legislation

Drug Product Hopping Bill Should Specify Anti-Competitive 'Window', Congress Advised

House bill in the works to deter brand product switches should specify what behavior would be unacceptable, legal experts testify at congressional hearing.

Legislation Legal Issues

‘Biased Trials Undermine EU Cancer Drug Approvals’

Nearly half of the pivotal randomized controlled trials supporting European marketing authorizations for new oncology drugs are at high risk of bias, claims a new study.

Europe Clinical Trials

‘Demystify’ Pricing, Say UK Parliamentarians

UK members of parliament have called on pharmaceutical companies to be more transparent in their pricing process and to improve the way they gather and present data for health technology appraisals. They also say that industry rebates should be ring fenced to fund new medicines.

Europe United Kingdom

Value-Based Contracts: Medicaid Best Price Concerns Could Be Eased With CMS Guidance

Absent any legislative remedy, an administrative fix could provide manufacturers with confidence that value-based arrangements won’t trigger a new best price, Duke Margolis policy experts propose.

Reimbursement Medicaid

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Legal Issues Policy
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