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    FDA Wins Federal Court Case Against Stem Cell Clinics

    A federal court on Monday ruled in favor of the US Food and Drug Administration (FDA) in a case over whether unapproved stem cell products can be considered adulterated and misbranded. US District Judge Ursula Ungaro of the Southern District of Florida ruled that stromal vascular fraction (SVF) cells can be a drug and subject to the Federal Food, Drug, and Cosmetic Act ’s (FDCA) adulteration and misbranding provisions. US Stem Cell Clinic LLC of Weston, FL and US Stem ...
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    House Appropriators Target Areas for FDA Improvement

    The House Appropriations Committee on Tuesday voted to send its FY 2020 spending bill for the US Food and Drug Administration (FDA) to the House floor, in addition to releasing a report explaining areas where FDA needs to focus its efforts. The funding bill would provide FDA with $3.26 billion in non-user fee funding, an increase of $184 million (6%) above the FY 2019 enacted level. According to the Alliance for a Stronger FDA, the bill is expected to be taken up on the...
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    Why Doesn’t FDA Publicly Disclose All NDAs and BLAs? Researchers Discuss

    Although current regulations prohibit the US Food and Drug Administration (FDA) from publicly disclosing new drug applications (NDAs) and biologics license applications (BLAs), a new JAMA Internal Medicine research letter reasoned that the agency should consider more transparency, because almost all NDAs and BLAs are publicly disclosed by their sponsors. “We found that information that the FDA treats as confidential with regard to applications for NDAs and BLAs was in...
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    FDA Launches Expanded Access Pilot ‘Project Facilitate’

    The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients.   “The FDA has been working diligently to improve the Expanded Access framework, including development of an updated and more streamlined application form, but despite recent improvements, we understand that for many patients or health care professionals, especially those not fami...
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    FDA Warns Pregnant Women Not to Take Vinpocetine

    The US Food and Drug Administration (FDA) on Monday issued a warning that consumption of the dietary supplement vinpocetine is associated with adverse reproductive effects. The FDA warning comes as a rat study conducted by the National Institutes of Health’s National Toxicology Program (NTP) found that vinpocetine decreased fetal weight and increased the chances of a miscarriage. “The blood levels of vinpocetine measured in the pregnant animals were similar to those ...
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    WHO Outlines Process to Designate Regulators as WHO-Listed Authorities

    As part of a shift from the term “stringent regulatory authority” to “WHO-Listed Authority” (WLA), the World Health Organization (WHO) in May discussed some of the details of an upcoming draft framework for evaluating and publicly designating regulatory authorities as WLAs. The concept note defines a WLA (including Maturity Level 3 WLAs and Maturity Level 4 WLAs), explains the process for applying for and being designated as a WLA and the process for finalizing the defi...
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    EU Gets a Leg Up on US With First New Gene Therapy for Blood Disorder

    The European Commission on Monday granted conditional marketing authorization for Bluebird Bio’s gene therapy Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) to treat a rare blood disorder. Zynteglo addresses the underlying genetic cause of transfusion-dependent beta-thalassemia (TDT), a rare inherited blood condition that causes severe anemia. The therapy, which has so far been evaluated in 11 patients, is intended for patients 12 years and older who nee...
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    Combination Products and MDR: EMA Offers New Draft Guideline

    With a focus on drug-device combination products, the European Medicines Agency (EMA) on Monday issued its second draft guideline as part of a series related to the EU’s medical device regulation (MDR). The draft guideline covers the documentation expected for drug-device combinations (DDCs) in the quality part of the dossier for a marketing authorisation application (MAA). DDCs falling within the scope of this guideline are medical devices that are integral to the medi...
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    FDA Chief of Staff to Step Down This Month

    The US Food and Drug Administration’s (FDA) Chief of Staff Lauren Silvis announced Monday that she will be stepping down from her role and leaving the agency in the next several weeks. Silvis, a former deputy center director for FDA’s Center for Devices and Radiological Health, moved to the role of chief of staff in 2017 when former FDA Commissioner Scott Gottlieb came aboard. Gottlieb said in a statement on Monday: “She was a strong manager drawn from within the...
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    Continuous Manufacturing: Industry Calls for Changes to FDA’s Draft Guidance

    Drugmakers and industry groups are calling for changes to the US Food and Drug Administration’s (FDA) recently released draft guidance, Quality Considerations for Continuous Manufacturing .   The 27-page draft guidance was released for comment in February and is part of FDA’s effort to encourage the adoption of continuous manufacturing, which the agency believes can improve consistency and reduce the risk of drug shortages.   While there is great interest in con...
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    Generic Drugmaker Admits to Price Fixing

    New Jersey-based generic drugmaker Heritage Pharmaceuticals admitted to fixing prices and will pay more than $7 million in criminal and civil damages, the Department of Justice (DOJ) announced Friday. Heritage admitted to conspiring to fix prices, rig bids and allocate customers for the Type 2 diabetes drug glyburide. In a separate civil resolution, Heritage has agreed to pay $7.1 million to resolve allegations under the False Claims Act related to price fixing. “The...
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    FDA’s First Hearing on CBD Opens a Path to Regulation

    The US Food and Drug Administration (FDA) held its first-ever public hearing Friday on products containing cannabis and cannabis-derived products, with advocates and critics calling for an efficient regulatory framework. FDA officials, including co-chairs of the agency’s internal working group on cannabidiol (CBD), FDA principal associate commissioner for policy Lowell Schiller and principal deputy commissioner Amy Abernethy, heard from nearly 100 hearing participants b...