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  • Regulatory NewsRegulatory News

    CDER Kicks Off Final Phase of OND Reorganization

    The reorganization of the FDA’s Office of New Drugs (OND) is nearing the finish line with a final round of changes to formally establish three new offices. According to an email from OND Director Peter Stein on Monday, Phase IV of the reorganization will formally establish the Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN); the Office of Immunology and Inflammation (OII) and the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medi...
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    FDA Unveils Guidance for Trials Impacted by COVID-19

    The US Food and Drug Administration (FDA) on Wednesday issued new final guidance to help sponsors assure the safety of trial participants, maintain compliance with good clinical practice (GCP) and minimize the risks to trial integrity during the COVID-19 pandemic. The guidance comes as the National Institutes of Health last week initiated the first COVID-19 vaccine Phase 1 trial in Seattle. Sanofi and Regeneron Pharmaceuticals also announced on Monday they have star...
  • Regulatory NewsRegulatory News

    MDCG Offers Flood of Guidance on Software, Class I Transitional Provisions and More

    The EU’s Medical Device Coordination Group (MDCG) released two new guidances and two updated guidances on Tuesday, offering device firms and notified bodies more details on what clinical evidence and performance evaluation is required for software under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), as well as further guidance on Class I device transitional provisions, and new versions of guidance on implant cards and unique device identifi...
  • Regulatory NewsRegulatory News

    FDA Warns Cipla Over Cross-Contamination Concerns

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to sent to a Goa, India-based manufacturing site of pharmaceutical company Cipla. Following a more than week-long inspection last September, FDA uncovered cross-contamination of products, noting, “Your testing confirmed the presence of active ingredients from a previous product in batches of the next product.” And the firm’s “lack of a clear root cause casts doubt on whether you have fully...
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    FDA Opens Path for States to Regulate COVID-19 Tests

    As part of efforts to speed the development of certain laboratory tests for COVID-19, the US Food and Drug Administration (FDA) late Monday updated guidance to enable states to oversee certain tests. “States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA,” FDA Commissioner Stephen Hahn said in a statement .   The shift comes as difficulties with the Emergency Use Authorization (EUA) ...
  • Regulatory NewsRegulatory News

    MDCG Offers MDR Implementation Plan, ‘Significant Change’ Guidance

    While acknowledging the implementation of the new EU medical device and in vitro diagnostic regulations (MDR and IVDR) has proven to be a “very challenging task,” the EU’s Medical Device Coordination Group (MDCG) last week outlined its plan for actions considered essential to have an operational system under MDR in place by 26 May. Medical device shortages across the region have been chief among the concerns floated by industry and other stakeholders, particularly as th...
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    US Biosimilar Launches About to Turn a Corner

    The US biosimilar industry has lingered in the shadow of the European market since the US pathway for approvals was initiated in 2009. Ten years later (or less than five years since the first FDA approval of a biosimilar), and just 46% (12 out of 26) of FDA-approved biosimilars have launched. But in the next three months (see chart below), a clutch of new biosimilars will hit the market, including new ones in oncology, hinting at a wave of uptake. For instance, Pfize...
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    FDA Looks to Help Ramp Up Testing for COVID-19 Across the US

    As the US continues to trail other countries in COVID-19 testing capacity, the US Food and Drug Administration (FDA) unleashed the private sector over the weekend, granting Emergency Use Authorizations (EUAs) to Roche and Thermo Fisher Scientific in vitro diagnostics. Roche’s cobas 6800/8800 Systems, which the company said are widely available, are used to perform the COVID-19 test and can provide results in three and half hours. The firm noted that the highest thro...
  • Regulatory NewsRegulatory News

    Legacy Devices: How MDR Alters the Landscape

    Medical devices with valid certifications under the Medical Device Directive (MDD) will have to prepare to adapt to the incoming Medical Devices Regulation (MDR), particularly for up-classified devices that will need more in-depth reviews from notified bodies. So what types of manufacturers should start considering how to transition their legacy devices between MDD and MDR? Most standalone software, many orthopedic implants, and closed loop active devices, according to ...
  • Regulatory NewsRegulatory News

    EU Begins Second Consultation to Revise Annex 1 of EU GMP Guide on Sterile Drug Manufacturing

    Since 1971, Annex 1 of the EU’s good manufacturing practice (GMP) guide has helped with the manufacture of sterile medicinal products, but now the European Commission, European Medicines Agency, PIC/S and WHO are launching a second consultation on fully revising the annex and introducing the principles of Quality Risk Management (QRM). The revised guidance notes that although QRM is not referred to in specific paragraphs, it “applies to this document in its entirety. ...
  • Regulatory NewsRegulatory News

    NDA to BLA Transition Hits Compounders, Authorized Generics

    In less than three weeks, the US Food and Drug Administration (FDA) will officially transition more than 100 new drug applications (NDAs) to biologics license applications (BLAs), which will not only impact biopharma companies but also drug compounders. This transition, dubbed the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 , was further explained in guidance finalized on Wednesday. Part of that guidance explains h...
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    User Fee Reauthorizations Begin With Public Meeting on MDUFA V

    The US Food and Drug Administration (FDA) on Thursday announced the first public meeting on 7 April to kick off the next round of Medical Device User Fee Amendments for fiscal years 2023 through 2027 (MDUFA V). The current user fee legislation (MDUFA IV) expires on 1 October 2022, and it spells out exactly how much device manufacturers must pay FDA for reviewing their various applications, and in turn, FDA has to meet certain goal dates for its reviews. Prior to be...