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User Fee Add-Ons: Senate Bill Tweaks Orphans, Opioids, Patient Data

 
• By Nielsen Hobbs

Manager's amendment tells US FDA to issue more guidance for complex generics and tells GAO to report on progress towards global harmonization of data standards.

Capitol House

The user fee legislation that the Senate HELP Committee will markup on May 10 is mostly the bland, renewal-only document (a "clean" bill in legislative parlance) that circulated last month, but a manager's amendment released May 8 gives a sense of where senators, while not exactly getting their hands dirty, have decided to nudge FDA.

The additions have mostly avoided the controversial topics of the day, even as the bill now skirts the pricing debate...

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Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules

 
• By Francesca Bruce

Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 
• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

Plans For EU Biotech Act Shift Up A Gear

 
• By Eliza Slawther

Companies have until early November to respond to a public consultation from the European Commission on its planned Biotech Act, which it hopes will help unleash the potential of small and midsize enterprises in the bloc.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By Vibha Sharma

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

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EMA Learns Hard Lessons From US-Inspired Streamlining Pilot

 
• By Vibha Sharma

The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.

UK Drug Pricing Scheme Talks Collapse: Industry Braces For Another Year Of High Rebates

 
• By Eliza Slawther

Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.

US FDA Suspends Valneva’s Ixchiq Based On Four New Serious AE Reports

 
• By Sue Sutter

After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.