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Latest News & Analysis

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

FDA: Key FY 2019 Warning Letter Trend Is Inadequate Testing For API Impurities

This year’s 89 warning letters so far hit API testing for nitrosamines, aseptic facility design, contaminated water, API traceability and more.

Manufacturing Quality

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

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Part D Out-Of-Pocket Cap Would Be $2,000 In House Drug Pricing Bill

It may seem perverse to look for silver linings for the drug industry in the House leaderships “price negotiation” bill. But if you can get past Title 1, the bill reads like an attempt to negotiate with the Senate Finance Committee – and it’s not all bad.

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
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