FDA panels: real‑world data and evidence can substitute where trials are infeasible — examples include alpelisib and Zolgensma FDA panelists reviewed standards for RWD/RWE (fit‑for‑purpose data, prespecified protocols, traceability) and cited cases where registries or expanded‑access data supported regulatory decisions — for example, alpelisib (PIK3CA‑related overgrowth) and Zolgensma (SMA) — while noting challenges around index dates, missing data and device identification.

FDA experts reveal how real-world data can reshape regulatory decisions, highlighting groundbreaking approvals like alpelisib and Zolgensma.

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#US #CitizenPortal #DataQuality #FDARealWorldData #PatientEvidence #RegulatoryDecisions

FDA study: many claims‑data real‑world analyses reach similar conclusions to randomized trials, with limits An FDA‑funded demonstration that emulated randomized trials in U.S. claims data found many real‑world data (RWD) studies produced results similar to the original randomized controlled trials (RCTs)—a Pearson correlation of 0.82—while underscoring important limits related to data capture and emulation choices.

A groundbreaking FDA study reveals that many claims-data analyses can yield results strikingly similar to randomized trials, but with significant caveats.

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#US #ClinicalTrials #CitizenPortal #RealWorldData #RegulatoryDecisions #USClaimsData

PURA Commissioners Approve Supplemental Decision on Poll Attachment Applications PURA declines prioritization of poll attachment applications pending further project details.

PURA's recent meeting revealed a crucial decision on pole attachment applications, leaving many projects in limbo as they await clarity on federal deadlines.

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#CT #CitizenPortal #CommunitySustainability #RegulatoryDecisions #EnergyInnovation

Expert highlights risks of US Treasury bonds amidst Silicon Valley Bank collapse Expert discusses yield rates and risks associated with Treasury bonds following bank bankruptcy.

Experts reveal surprising risks in U.S. Treasury bonds, raising questions about their safety after the Silicon Valley Bank collapse.

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#CT #FinancialRisk #CitizenPortal #RegulatoryDecisions #UtilityPricing

EU antitrust regulators to decide on SES, Intelsat deal by June 10 Blog Mobile Portfolio Widgets About Us Advertise Help & Support Authors Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks. Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed. Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website. It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website. Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.

Click Subscribe #EUAntitrust #SES #Intelsat #MergersAndAcquisitions #RegulatoryDecisions

FERC Actions Recent Orders and Key Developments FERC Actions: Recent Orders and Key Developments A review of recent Federal Energy Regulatory Commission (FERC) actions reveals several key themes involving natural gas infrastructure, hydropower development, and grid interconnection. These actions, categorized by Order type (Enforcement/Orders, Certificates, Hydropower), offer insights into current trends and regulatory decisions. Enforcement and Order Highlights: Several orders address facility abandonments and sales, notably involving the Venice Gathering System and Cimarron River Pipeline. The Venice Gathering System’s abandonment signifies the relinquishment of ownership of related pipeline infrastructure. Similarly, Cimarron River Pipeline’s sale to DCP Operating and subsequent abandonment of related certificates highlights infrastructure transitions, with FERC issuing a declaratory order confirming DCP Operating’s gathering function is outside FERC’s jurisdiction. Ratts 2 Solar LLC received a waiver to extend a commercial operation deadline for a generator interconnection agreement. York Energy Storage LLC’s preliminary permit for a waterpower project was reaffirmed following a rehearing request. Premium Energy Holdings, LLC received a preliminary permit term extension but had a request for a new preliminary permit for a pumped storage project denied. Ratts 2 Solar LLC again was granted a waiver extending a commercial operation deadline in its generator interconnection agreement. Certificate Order Summaries: Consistent with the Enforcement Orders, the Certificate Orders concerning the Venice Gathering System and Cimarron River Pipeline detail the approvals for abandonment and sales respectively. The declaratory order related to DCP Operating’s acquisition clarifies its jurisdictional status. Hydropower Order Actions: Hydropower developments are reflected in orders pertaining to York Energy Storage LLC, where a preliminary permit was upheld after a rehearing, and Premium Energy Holdings, LLC which secured a preliminary permit extension while a new permit request was denied for a pumped storage project. Overall Observations: The recent FERC orders suggest a pattern of infrastructure adjustments, with approvals for facility abandonments and sales. Extensions and waivers are common, particularly concerning generator interconnection agreements and preliminary permits. Development of hydropower projects, including preliminary permits and responses to rehearing requests, also remains an active area of regulatory oversight.

FERC Actions Recent Orders and Key Developments #MISO #FERC #RegulatoryDecisions #HydropowerDevelopment #GridInterconnection #EnergyPolicy

Painful decision-making at FDA The FDA is critical in ensuring that medications are safe and effective. However, the FDA's decision-making process for opioid analgesics is complicated by the need to address patients with complex...

An important editorial: "Painful decision-making at the FDA@DavidJuurlink #opioids #bioethics #regulatorydecisions

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