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    EU Regulatory Roundup: UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Politicians Tell Government to Grant Debates on No-Deal Drug, Device Legislation   Committees of British politicians have pushed back against the government’s attempts to adopt new drug and medical device legislation without holding debates in Parliament.   Last month, the UK government proposed changes to legislation intended to ensure the rules covering dru...
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    European Parliament Passes SPC Waiver in Landslide Vote

    The European Parliament on Wednesday voted through a proposal to allow manufacturing waivers to supplementary protection certificates (SPCs) by an overwhelming majority, with more than 75% of members voting in favor of the measure.   In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse b...
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    EU Takes Another Step Towards Adopting SPC Waiver Proposal

    The European Union’s proposal to allow manufacturing waivers to supplementary protection certificates (SPC) is one step closer to adoption after EU ambassadors endorsed a compromise reached on 14 February with the European Parliament during a meeting of the Committee of the Permanent Representatives (Coreper) on Wednesday.   Now that the draft regulation has been agreed to, it will undergo a legal and linguistic review before being sent to the European Parliament and C...
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    Industry, Advocacy Groups Seek Clarity on Proposed Changes to Informed Consent Rules

    Trade associations representing the medical device and clinical research industries, as well as the nonprofit public advocacy organization Public Citizen, are calling for the US Food and Drug Administration (FDA) to clarify provisions of its proposed rule for institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for certain clinical trials involving minimal risk to participants.   Background   Under current FDA regulations...
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    EU Advances SPC Waiver Proposal

    The European Union's proposal to allow manufacturing waivers to supplementary protection certificates (SPC) took a step forward on Wednesday after EU ambassadors backed the EU Council's position on the proposed regulation during a meeting of the Committee of the Permanent Representatives (Coreper).   "The draft regulation is expected to remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established o...
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    Generic and Branded Industry Groups Spar Over EU SPC Waiver Proposal

    The European Parliament’s International Trade Committee (INTA) on Monday voted to adopt a draft opinion supporting changes to an amendment that would allow for manufacturing waivers to supplementary protection certificates (SPCs).   In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse be...
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    FDA Issues Two Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

    The US Food and Drug Administration (FDA) on Tuesday issued two draft guidances aimed at updating its recommendations for in vitro diagnostics (IVDs) seeking a waiver from requirements under the Clinical Laboratories Improvement Amendments (CLIA) in line with provisions of the 21st Century Cures Act and the recently reauthorized Medical Device User Fee Amendments (MDUFA IV). Under CLIA, clinical laboratories must obtain a certificate to perform complex diagnostic t...
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    CLIA Waiver Decisions: FDA Begins Posting Summaries

    The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part of a pilot to boost transparency. FDA also updated its guidance on its administrative procedures for CLIA categorization for IVDs to reflect new commitments under the recently reauthorized Medical Device User Fee Amendments (MDUFA IV). So far, the agency has posted de...
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    EMA Announces Sweeping Overhaul of Pediatric Class Waivers

    In a major move, the European Medicines Agency (EMA) announced today it is revoking or revising most product class waivers that allow companies to bypass the requirement to test new drugs in pediatric populations before they can be authorized. Background Companies are often reluctant to conduct clinical studies in children over ethical concerns and fear of adverse events occurring during trials. These reservations have created a gap in the number of products authorized ...
  • After Controversy, FDA Finalizes New Policy on Advisory Committee Transparency

    A new guidance document published by the US Food and Drug Administration (FDA) is intended to clarify how financial information about members of its advisory committees should be made available to the public. Background FDA's advisory committees are used regularly to make recommendations regarding regulatory topics, such as the approval of a new drug product or the need for a new regulatory approach. While their recommendations are not binding on the agency, they are ne...
  • New Guidance on Conflict of Interest Disclosures for Advisory Committees

    The US Food and Drug Administration (FDA) released new draft guidance on 8 March about the availability of conflict of interest information and waiver information for members of advisory committees. The guidance also establishes a procedure for disclosing financial interest and granting conflict-of-interest (COI) waivers to special Government employees (SGEs) and regular employees. The guidance also provides a standardized mechanism for public disclosure of such document...
  • FDA: 99% of Establishment Registrations Now Electronic Post-FDAAA

    The US Food and Drug Administration (FDA) is reporting today via the Federal Register that the overwhelming majority of establishment registrations are now taking place electronically, including initial establishment registrations, foreign registrations and annual registrations. The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes sections 222, 223 and 224, which regulate the registration of establishments under Section 510 of the Federal F...