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    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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    Swissmedic Updates on Breast Implant Associated-anaplastic Large Cell Lymphoma

    Swissmedic said Monday that based on the currently available information, the association Swiss Plastic Surgery recommends using smooth implants rather than textured implants where permitted by the clinical situation. France’s National Agency of Medicine and Health Products (ANSM) echoed that recommendation after observing most known breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) cases in patients with textured breast implants. But the committee doe...
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    E&C Leaders Seek FDA Briefing on Contaminated Sartans

    A bipartisan group of lawmakers who serve on the US House Committee on Energy and Commerce (E&C) sent a letter to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday to request a briefing on the sartan safety issues that prompted a string of recalls worldwide. “Beginning in July 2018, there have been at least 15 recalls issued for a variety of angiotensin II receptor blockers (ARB), which are generally used to treat high blood pressure,” the E...
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    Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh

    A panel of outside experts convened by the US Food and Drug Administration (FDA) on Tuesday deliberated on available evidence and patient testimonies regarding the use of transvaginal mesh implants and advised the agency to consider adverse event reports when conducting premarket reviews. The panel, which was largely compromised of medical doctors, heard from patients who experienced a range of health complications following implantation of the surgical mesh. This marke...
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    FDA Drafts Guidance on Developing Drugs for Rare Chronic Digestive Disorder

    The US Food and Drug Administration (FDA) issued draft guidance on Wednesday to aid sponsors in the clinical development of drugs and biologics for the treatment of eosinophilic esophagitis (EoE). The 13-page draft guidance document describes the agency’s clinical trial recommendations for EoE drugs. These relate to trial population and design, safety and efficacy considerations, clinical outcomes assessments, as well as pediatric considerations. The clinical developmen...
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    ICH Seeks to Harmonize Generic Drug Standards

    With an aim to harmonize the technical and scientific standards for generic drugs across borders, the International Council on Harmonization (ICH) on Wednesday released a reflection paper outlining an approach to begin supporting such efforts. The reflection paper offers recommendations to develop a series of ICH guidelines on standards for demonstrating bioequivalence for non-complex and more complex dosage forms and products. It also describes the remit of the Informa...
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    House E&C Questions Insulin Manufacturers

    The House Committee on Energy and Commerce (E&C) on Wednesday sent letters to the three insulin manufacturers serving the US: Eli Lilly, Novo Nordisk and Sanofi, seeking more information on the root causes of the rising cost of insulin. First discovered more than 100 years ago, average insulin prices nearly tripled between 2002 and 2013 and then nearly doubled between 2012 and 2016, with patients bearing the brunt of those price spikes. Now, just a day after two moth...
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    House, Senate Hearings Address Pharmaceutical Prices

    The House Oversight Committee and the Senate Finance Committee on Tuesday held hearings addressing the rising cost of prescription drugs, with both committees featuring mothers of insulin-dependent children, including one whose daughter died because of rationing due to the cost of insulin. Senate Finance Chair Chuck Grassley (R-IA) and others stressed the need for an investigation into the rising cost of insulin. “We need to continue to have a strong research engine ...
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    510(k) Modernization: FDA Floats Need to Pursue New Authority

    Plans at the US Food and Drug Administration (FDA) to “modernize” the most commonly used pathway for new medical device clearances “might require new authority,” FDA leadership said on Monday. FDA Commissioner Scott Gottlieb and Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), issued a joint statement to announce 2018 progress on novel device approvals, pointing out that the breakthrough 510(k) is one of two submission types that was new...
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    European Commission Updates Q&A on Safety Features for Medicinal Products

    The European Commission recently released an updated document setting out nine new and one revised frequently asked questions and answers on the implementation of the rules on the safety features for medicinal products for human use. Building off a previous update in November , five of the new questions deal with general issues, like whether medicinal products can carry more than one batch number, or whether during the transitional period manufacturers located in the E...
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    CDRH Outlines Next Steps to Implement New Safety and Performance Based Pathway

    Following Tuesday’s final guidance that established a new option for 510(k) clearance, a spokesperson from the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) highlighted next steps to implement the new Safety and Performance Based Pathway in 2019. “Our next step is to develop an implementation plan to apply this Safety and Performance Based Pathway,” CDRH spokesperson Angela Stark told Focus . “We encourage industry and o...
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    FDA Launches Probe into Drug-containing Balloons, Stents

    Paclitaxel-coated balloons and paclitaxel-eluting stents prompted a US Food and Drug Administration (FDA) letter to health care providers after a 2018 meta-analysis suggested an increased mortality rate in patients that received peripheral arterial disease (PAD) treatment with either of the device types. All-cause patient mortality rate at two years “significantly increased” and “increased further” after up to five years, following use of paclitaxel-coated balloons or p...