• Regulatory NewsRegulatory News

    FDA Proposes New Rule for Sunscreen Products

    The US Food and Drug Administration (FDA) proposed a new rule on Thursday to update regulatory requirements for most sunscreen active ingredients currently on the US market. The 264-page proposed rule was decades in the making, with collaborators ranging from agency staff and outside scientific experts to patient advocacy groups. The new regulatory framework it describes is aimed at providing better assurance of the safety, efficacy and preventive qualities of over-the-...
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    Under Pressure from Congress, FDA Holds Firm on Rejection of new Sunscreen Ingredients

    Despite congressional pressure to approve several new sunscreen ingredients long pending before reviewers, the US Food and Drug Administration (FDA) says it will not bow to pressure and will instead continue to insist the companies provide it with data to show the products are both safe and effective. Background FDA's regulation of sunscreen ingredients popped up as a major issue starting in late 2013, when sunscreen manufacturers banded together to form a coalition ...
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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...
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    Bill to Speed up Approvals for Sunscreen Ingredients, Other Drugs Awaits Obama's Signature

    US legislators in the House of Representatives have passed a Senate bill which would overhaul the manner in which the US Food and Drug Administration (FDA) approves sunscreen ingredients and other products through a rarely used regulatory pathway known as the Time-and-Extent process (TEA), all but assuring the bill will be passed into law. Background The bill, known as the Sunscreen Innovation Act (SIA) , follows extensive complaints by several companies that their sun...
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    Senate Bill Seeks Faster, More Predictable Approvals for Time and Extent Applications

    Senate legislators have released a new iteration of the Sunscreen Innovation Act , a bill which seeks to accelerate the approval of long-delayed new sunscreen ingredients in the US, which would go beyond sunscreen ingredients to overhaul part of the process used to approve over-the-counter (OTC) drugs. Background As explained in our article on the House version of the Sunscreen Innovation Act , the bill has long been focused on the Time and Extent (TEA) application ...
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    House Legislators Clear Sunscreen Innovation Bill, but Questions Remain

    The US House of Representatives has voted in favor of a bill that would require the US Food and Drug Administration (FDA) to speed up its assessment process for new sunscreen ingredients that have been awaiting regulatory approval for as long as a decade in some cases. Background The bill, the Sunscreen Innovation Act (H.R. 4250) requires FDA legislators to speed up their review of sunscreen ingredients submitted under the Time-and-Extent Application (TEA) process. ...
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    Bill Would Expedite FDA Approvals for Drugs, Devices Given OK by EU Regulators

    When the US Food and Drug Administration (FDA) approves a drug, its primary concern is with the product's safety, efficacy and quality. But a secondary concern is what is known as "drug lag"—the time between when a product was first approved for use elsewhere in the world and when it was approved in the US. Background: Drug Lag The issue of drug lag was once a major concern in the US, which largely lagged behind the EU in drug approvals, but has largely fallen int...
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    Sunscreen Innovation Act Advances in House, Seeks FDA Action on New Ingredients

    Legislators are preparing to move forward with legislation that would require the US Food and Drug Administration (FDA) to take action on the approval of new sunscreen ingredients, a collection of which have been pending before the agency for years, and in some cases more than a decade. Background HR 4250 , known as the Sunscreen Innovation Act , is co-sponsored by Reps. Ed Whitfield (R-KY) and John Dingell (D-MI) and required FDA legislators to speed up their r...
  • Regulatory Explainer: Understanding the Regulation of New Sunscreen Ingredients

    For the last few years, the US Food and Drug Administration (FDA) has come under fire from advocates of new sunscreen ingredients who claim the agency has been dragging its feet at the expense of consumers. As part of our ongoing series of Regulatory Explainers , we thought we would break this issue down to make it easier to understand. What Kinds of Products Contain Sunscreen? Sunscreen ingredients are in a huge number of consumer skin products. Pick up almost any t...
  • FDA to Delay Implementation Date for Sunscreen Labeling and Testing Changes

    The US Food and Drug Administration (FDA) announced 10 May it will delay implementation of a final rule intended to establish labeling and effectiveness testing for over-the-counter (OTC) sunscreen products, marking the latest development in a long struggle over the regulation of sunscreen products. FDA's final rule establishes new requirements for sunscreen products containing specific active ingredients and marketed without approved applications, "amends labeling claim...
  • Report: Clashes Between White House, FDA Frequent

    A report in The New York Times indicates the US Food and Drug Administration (FDA) and the Obama Administration are frequently at odds-partially the result of poor communication and partially the result of poor political optics-which has caused significant amounts of tension between the two government bodies. The report notes numerous instances where the Administration and FDA have clashed, including the banning of Primatene asthma inhalers, Health and Human Services S...