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Senate Budget Draft Would Be Less Generous To US FDA Than House For FY 2023

 
• By Derrick Gingery

Senate appropriations bill would take back some of the increase the House offered the Center for Drug Evaluation and Research and other programs, setting up negotiations as next fiscal year nears.

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The Senate offered less of an increase in FY 2023 funding for the FDA than the House of Representatives. • Source: Shutterstock

The Senate is starting deliberations on US Food and Drug Administration funding for fiscal year 2023 from a less generous stance than the House of Representatives, setting the stage for negotiations over potentially wide differences before 1 October, when the new spending plan would start. 

Both would give increases to the agency, but the Senate proposal is more conservative. The current Senate figures, outlined in a 

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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
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EU Pharma Reform: Exclusivity Vouchers Alone Are Insufficient Incentive For Antimicrobials, Industry Says

 
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Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
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The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.