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    Global medicinal supply chain examined in EC, US efforts

    The European Commission has launched a structured dialog addressing pharmaceutical supply chain initiatives, aiming to safeguard the security of the European Union’s supply of medicines. A 26 February launch meeting kicked off the structured dialog initiative, which brings together national authorities, patients, nongovernmental organizations working in the health sector and members of the research community.   By coming to a clearer understanding of how global medical...
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    EMA Contests Two Judicial Decisions Over Clinical Trial Transparency Efforts

    The European Medicines Agency (EMA) on Thursday announced it has appealed two interim orders by the President of the General Court of the EU, which suspended the release of clinical study documents requested by third parties under a new transparency regulation. The first order blocked the release of a study report for PTC Therapeutics’ Translarna (ataluren), a Duchenne’s muscular dystrophy treatment, until a final ruling is provided. EMA says it was planning to provid...
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    Obama’s FY 2017 Budget Request: $5.1B for FDA, New Ways to Tackle High Drug Prices

    President Barack Obama unveiled his final budget request on Tuesday, and though Republicans have said it’s dead on arrival, the US Food and Drug Administration (FDA) would receive an 8 percent increase in funds to help further address drug compounders, device submissions and supply chain security. New ways to combat high prescription drug prices were also included in the request. The overall request from Obama and FDA includes a net increase of $14.6 million in budget au...
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    Senators Urge Obama to Take Action on Drug Prices

    Policy solutions to bring down the rising tide of prescription drug prices should be included in next year’s budget, eight senators said in a letter sent to President Barack Obama on Tuesday. Examples of ways Obama could help to lower drug costs include requiring drugmakers to provide rebates on prescriptions for Medicare Part D low-income subsidy enrollees “in the same way that it does already for Medicaid recipients,” the senators said, noting that about $120 billion c...
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    US Special Counsel Finds FDA Whistleblower's Device Approval Concerns Unsubstantiated

    The claims of an anonymous whistleblower within the US Food and Drug Administration (FDA) that employees of the Center for Devices and Radiological Health (CDRH) created public health dangers by approving the use of a digital mammography device and several colonography devices were found to be unsubstantiated, according to a letter sent by the US Office of Special Counsel (OSC) to President Barack Obama. Background Six staff scientists, former employees of CDRH's Office...
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    FDA Legislation Tracker

    Each year, legislators introduce dozens of pieces of legislation hoping to change how the US Food and Drug Administration (FDA) regulates pharmaceuticals, medical devices, biologics and dietary supplements. Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often. Can't find legislation you know exists...
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    Obama: Let's Take Food Regulation out of FDA

    The US Food and Drug Administration (FDA) could stand to lose all of its authority to regulate food products, potentially including dietary supplements, under a new proposal unveiled by President Barack Obama this week. Background The proposal, contained within Obama's budget proposal for fiscal year 2016, would consolidate all regulatory authority for food under a "single new agency within The Department of Health and Human Services," according to the budget. "This ne...
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    Legislators to Obama: Help us in Effort to Reform FDA Regulation

    For months, legislators on the House Energy and Commerce (E&C) Committee have been working with a large group of stakeholders in the hopes of developing a series of reforms to the way the US Food and Drug Administration (FDA) approves new drugs and medical devices. Now the committee has reached out in the hopes of recruiting one especially important stakeholder to its cause: President Barack Obama. Background The legislative effort, known at the 21st Century Cures Init...
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    Obama Signs Special Ebola Incentive Program Into Law

    President Barack Obama has signed a new bill into law allowing any pharmaceutical or biotechnology company that successfully develops a product to treat the Ebola virus to obtain a special voucher potentially worth millions—and even billions—of dollars. The law, Adding Ebola to the FDA Priority Review Voucher Program Act , was signed into law by Obama on 16 December 2013. The law focuses on FDA's neglected tropical disease priority review voucher (PRV) program, a pro...
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    Obama Approves Bill Reforming Regulation of Sunscreen Ingredients, Other Drugs

    US President Barack Obama has signed into law a new bill set to change the way in which some drugs, and in particular sunscreen ingredients long approved in other countries, are regulated by the US Food and Drug Administration (FDA). Background The bill, the Sunscreen Innovation Act (SIA), was signed into law by Obama on 26 November 2014 following its passage in the House of Representatives on 14 November 2014. The bill's passage follows extensive complaints by s...
  • Obama Signs New FDA User Fee Bill for Veterinary Pharmaceuticals Into Law

    US President Barack Obama has signed into law a new piece of legislation that is set to increase the amount of funding given to the US Food and Drug Administration (FDA) by the veterinary pharmaceutical industry in the hopes of speeding up review and clearance times for product applications. Background The legislation, known as the  Animal Drug and Animal Generic Drug User Fee Reauthorization Act (ADAGDUFRA) , is an amalgamation of the Animal Drug User Fee A...
  • President Signs into Law Budget Bill that Restores FDA's Authority to Spend User Fees

    A new budget resolution passed into law by President Barack Obama on Wednesday will for the first time allow the US Food and Drug Administration (FDA) to spend tens of millions of annual user fees the agency had already been authorized to collect under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, but had been unable to spend under its existing budgetary authority. Background The fees are responsible for funding a significant portion of ...