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    FDA reiterates support for semi-distributed tracing model under DSCSA

    The US Food and Drug Administration (FDA) recommends that trading partners use the semi-distributed model to trace drug products though the drug distribution chain because of this model’s flexibility and advantages over other data architecture models. The Drug Supply Chain Security Act (DSCSA) requires that trading partners have these systems in place by November 2023.   Connie Jung, acting associate director for policy and compliance in FDA’s Office of Drug Security, ...
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    FDA official: Growing number of enforcement actions stem from inspection alternatives

    Many of the US Food and Drug Administration’s (FDA) drug good manufacturing practice (GMP) warning letters and import alerts issued in fiscal year 2021 were based on product sampling and reviewing firms’ written responses to record requests, not from traditional onsite inspections.   So asserted Francis Godwin, director of Office of Manufacturing Quality (OMQ) in FDA’s Center for Drug Evaluation and Research (CDER) at a compliance and enforcement update at a 26 October...
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    Nitrosamine detection tests should be 'fit for purpose,' says FDA

    Pharmaceutical manufacturers should ensure that the analytical tests they are using are “fit for purpose” to ensure that the right test is measuring the right impurity in testing their drugs for nitrosamines, says Jason Rodriguez, director of the division of complex drug analysis at the US Food and Drug Administration’s (FDA’s) Office of Testing and Research in St. Louis. Manufacturers should also use orthogonal, or additional methods, to double-check results.   Rodrig...
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    FDA announces stronger warnings on breast implant labels

    The US Food and Drug Administration on 27 October announced new labeling, including boxed warnings, to facilitate informed consumer decision-making regarding the risks of breast implants.   FDA is also restricting the sale and distribution of breast implants to providers who agree to provide patients with adequate information on their risks by reviewing a decision checklist with patients. The physician performing the breast implant must sign the checklist, and patien...
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    ICH Q12 guideline draws more comments from industry

    A major pharmaceutical industry group is calling for the US Food and Drug Administration (FDA) to institute several revisions to the International Council for Harmonization’s (ICH) Q12 guideline on postapproval changes.   The document was released by FDA for public feedback in May. (RELATED: ICH Q12: FDA guidance explains US implementation, Regulatory Focus , 21 May 2021).   The International Society for Pharmaceutical Engineering (ISPE) suggested in its 8 Oct...
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    European Commission identifies 10 ‘promising’ COVID treatments

    The European Commission (EC) on 22 October released a list of the 10 “most promising treatments” for COVID-19 as part of its strategy to support the development of new therapies.   A panel of scientific experts selected the 10 drugs from a pool of 82 therapeutic candidates that are in late-stage clinical development.    “In selecting the 10 most promising candidates, experts focused on the product categories with the highest potential impact on the pandemic: produc...
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    FDA encourages industry to adopt modeling tools to ensure stable processes

    An official with the US Food and Drug Administration (FDA) encouraged the pharmaceutical industry to adopt advanced process control (APC) modeling tools to ensure that manufacturing processes are operating in a state of control, asserting that these processes are often reactively monitored rather than proactively controlled.   “Our process capabilities remain at two or three sigma, because we are relying on manufacturing of the last century,” said Stelios Tsinontides, ...
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    Continuous manufacturing bill clears House

    The US House of Representatives on Tuesday night passed a bill , H.R. 4369, that promotes advanced manufacturing through the creation of national centers for excellence in continuous manufacturing at various universities across the country.   The House also passed another bill, H.R. 3635 , which would make changes to the management of the Strategic National Stockpile to help the response to the current pandemic and future public health emergencies by allowing transfe...
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    FDA chastises three US firms for ignoring record requests, inadequate CMO oversight, and shoddy response to fires

    Inadequate oversight of contract manufacturers, failing to address how a fire affected the quality of active pharmaceutical ingredients, and ignoring the agency’s request for electronic records prompted the US Food and Drug Administration (FDA) to issue three warning letters for good manufacturing practice (GMP) violations to an over the counter drug manufacturer, a finished drug manufacturer and an API manufacturer in the US.   The recipients of the warning letters, w...
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    FDA shows jump in competitive generic approvals

    The US Food and Drug Administration (FDA) approved a steadily increasing number of competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) in FY 2021 while the number of priority generic approvals leveled off, according to agency’s quarterly data on reviews and approvals of priority and competitive generics.   FDA approved 29 priority ANDAs in FY 2021, one more than the 28 approved in  FY 2020 . There was an increase of about 8% in the number of ...
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    EMA shares lessons learned from biosimilars pilot

    The lack of mature quality data, such as sufficient batch data, hindered the ability of the European Medicines Agency (EMA) to provide scientific advice to sponsors on their biosimilar development programs, according to a report on the agency’s recently concluded biosimilar scientific advice pilot.   Also, EMA found that current regulatory guidelines, which assume that developers will take a stepwise approach to biosimilar development where clinical studies are condu...
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    FDA says IRB review still needed for IVD studies involving human specimens

    The US Food and Drug Administration (FDA) reiterates that clinical studies of in vitro diagnostic devices (IVDs) using leftover, "deidentified" human specimens still have to be approved by Institutional Review Boards (IRBs).   This pronouncement was made in an 18 October reminder letter to IVD manufacturers by William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality within FDA’s Center for Devices and Radiological Health. ...