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    FDA reports rare complications with Pfizer COVID vaccine, updates J&J safety info

    A summary of results of near real-time monitoring of the safety of COVID-19 vaccines in  older individuals was reported Tuesday by the US Food and Drug Administration (FDA). The agency identified four potential health concerns associated with receiving one of the authorized vaccines.   Examining the database of Medicare health care claims for people aged 65 years and older who received the mRNA vaccine marketed by Pfizer/BioNTech, FDA identified four adverse events o...
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    MDCG offers guidance on IVDR codes

    The European Commission’s Medical Device Coordination Group (MDCG) on Tuesday released a document explaining the use of codes under the In Vitro Diagnostic Regulation (IVDR).   MDCG says the explanatory note “is intended to explain the different levels of codes and how they should be used, including the use of conditions to ensure a harmonised use of the codes especially for the allocation of resources to conformity assessment activities.”   The codes, which are ...
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    FDA sees different tactics were successful in established conditions pilot

    Manufacturers leveraged diverse approaches to defining established conditions (ECs), a core tenet of the International Council for Harmonization’s (ICH) Q12 guideline for managing post-approval changes, in its recently concluded EC pilot program, said US Food and Drug Administration (FDA) officials at a recent meeting.   Christopher Downey, review chief in FDA’s Office of Biotechnology Products in the drug center’s Office of Pharmaceutical Quality, spoke of some of the...
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    EMA guidelines highlight changes to IMPs triggering notification to regulators

    The European Medicines Agency (EMA) on 1 July released for public consultation two draft guidelines to help sponsors of investigational medicinal products (IMPs) for new drugs and biologics decide whether manufacturing changes are considered a “substantial modification” needing prior approval.   These guidelines are connected to the EU regulation No. 536/2014 which came into force on 20 June 2014. The regulation defines a “substantial modification” as any change to a...
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    Biden’s competition order directs FDA on biosimilars, importation and OTC hearing aids

    Prescription drug pricing, generic and biosimilar competition, and access to over-the-counter (OTC) hearing aids are among the targets of a sweeping executive order signed by President Joe Biden on Friday.   The order, aimed at promoting competition in the US marketplace across several sectors, calls on the Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) to advance several policies that are already planned or underway, includ...
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    CBER Q&A addresses stem cell enforcement questions

    The US Food and Drug Administration (FDA) issued a question-and-answer document on Monday to address issues that may arise now that the agency's enforcement discretion policy against unauthorized marketing of these products has come to an end.   The agency’s Center for Biologics Evaluation and Research (CBER) ended a period of enforcement discretion against purveyors of unauthorized human cells, tissues, or cellular or tissue- based products (HCT/Ps) on 31 May 2021. Ac...
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    Woodcock calls for investigation into Aduhelm approval

    The US Food and Drug Administration’s acting head has called on the Inspector General at the Department of Health and Human Services to conduct an investigation into matters related to the agency’s recent controversial approval of Biogen’s new Alzheimer’s disease drug Aduhelm (aducanumab).   Janet Woodcock, acting director of the US Food and Drug Administration (FDA), took to Twitter early Friday afternoon to make the announcement, sharing the letter she sent to Christ...
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    EMA's PRAC weighs in on more vaccine side effects

    The European Medicines Agency (EMA) has weighed in on several rare adverse events for COVID-19 vaccines and one gene therapy for treating thalassemia in their latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting.   At its July meeting, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found mRNA-based COVID-19 vaccines, like Pfizer’s Comirnaty and the Moderna vaccine marketed in the EU as Spikevax, carry a small risk of myocarditis and pericarditis....
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    FDA trims Aduhelm's indicated population

    Biogen’s newly approved Alzheimer’s disease drug Aduhelm (aducanumab-avwa) received a labeling update Thursday to clarify that the drug is meant for individuals with mild cognitive impairment or dementia due to Alzheimer’s disease.   Just last month, Aduhelm received accelerated approval from the US Food and Drug Administration (FDA), a controversial decision that ran counter to the strong opinions of the agency’s Peripheral and Central Nervous System advisory committe...
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    Appeals court overturns FDA’s ban of electric shock device

    In a 2-1 decision, a federal court of appeals in Washington, DC struck down the US Food and Drug Administration’s (FDA) ban on electrical stimulation devices (ESDs) used at a single facility in Massachusetts to treat self-injurious behavior (SIB) or aggressive behavior (AB).   The US Court of Appeals for the DC Circuit, in siding with the plaintiffs, found that FDA’s ban on the devices for their particular use is not supported under statute and infringes on the practic...
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    FDA calls for new warning labels on hydroxyethyl starch products

    The US Food and Drug Administration (FDA) on Thursday says it is requiring new safety warnings for hydroxyethyl starch (HES) products in light of reports of death, kidney injury and excessive bleeding associated with these products.   HES treatments are used to stabilize patients experiencing severe blood loss. The announcement follows up on an FDA safety review of these products from randomized clinical trials, meta-analyses, and observational studies. Through this re...
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    EMA updates Q&A on nitrosamine assessment and testing

    The European Medicines Agency (EMA) has published an updated “question and answer” guidance describing how manufacturers should assess the risk of nitrosamine impurities in drug products and how to test products for these impurities.   It contains minor revisions from a previous version published last year. (RELATED: EMA addresses risk evaluation, mitigation for nitrosamines , Regulatory Focus, 6 August 2020) . EMA wants marketing authorization holders (MAHs) ...