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    REMS Format and Content: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Wednesday released updated recommendations in the form of a draft guidance for the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drugs and biologics. The 34-page draft revises 2009 draft guidance for industry known as, "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications." FDA notes at the outs...
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    Status Updates for ANDAs: FDA Spells Out GDUFA II Provision

    Under the second iteration of the Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) has agreed to provide timely abbreviated new drug application (ANDA) review status updates for all pending ANDAs. The updates for applicants on their ANDA review status will include the issuance of Information Requests (IRs) and Discipline Review Letters (DRLs), and to provide applicants with an advance notification of regulatory correspondence, includ...
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    Some FDA Medical Device, Generic Drug User Fees Spike in FY 2018

    Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements. For instance, device companies submitting 510(k) applications, which are for devices equivalent to ones already marketed, fees wi...
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    EMA Updates Guidance on Three Post-Authorisation Activities

    The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations. "The main aim is to improve the quality of post-authorisation applications by better assisting applicants in complying with the legal and regulatory requirements and avoiding frequent mistakes," EMA writes. Specifically, the updates include a new pre-submission c...
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    FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements

    The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. Established under the 21st Century Cures Act, the list, first published in draft form in March , is part of efforts to decrease regulatory burdens and costs for the device industry. For the complete f...
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    European Regulatory Roundup: New Gateway for Parallel Consultations on Marketing Authorizations, HTAs (6 July 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA, EUnetHTA Create Gateway for Parallel Consultations on Marketing Authorizations, HTAs European regulators and health technology assessment (HTA) bodies have advanced their plans to align the data sponsors need to win approval and secure reimbursement. The initiative takes the form of a gateway through which sponsors can request parallel consultations with the Europe...
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    HHS Secretary Pushes to Cut FDA Appropriations, Replace With More Industry Fees

    Secretary of Health and Human Services (HHS) Tom Price is continuing to push the Senate to further increase the industry fees paid to the US Food and Drug Administration (FDA), which would upend the agreed-to amounts negotiated by FDA and industry for the next five years, and allow for further cuts to the agency’s congressional appropriations. Last week, the Senate Health, Education, Labor & Pensions (HELP) committee advanced a bill reauthorizing the user fee pro...
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    BD, Roche Weigh FDA’s Proposed Exemptions for Class II Devices

    Beckton, Dickinson and Co. (BD) and Roche Diagnostics are seeking clarifications and changes to the US Food and Drug Administration’s (FDA) proposed list of Class II medical devices to be exempted from premarket notification. The comments follow the release in March of FDA’s draft list , which was released as part of a provision in the 21st Century Cures Act . The devices listed include lots of basic diagnostic tests and reagents, as well as other equipment like ...
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    FDA Drafts List of Class II Devices to be Exempt From Premarket Notification

    The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s. FDA said in a statement that it “believes that the devices identified in the Federal Register are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safe...
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    FDA Explains How GDUFA II Will Help Small Businesses

    The US Food and Drug Administration (FDA) on Thursday offered more details on how the second iteration of the Generic Drug User Fee Act (GDUFA), which must be approved by Congress and President Donald Trump by the end of September 2017, will improve upon the first. One of the biggest proposed changes between the two programs is the creation of a new user fee structure, which was also outlined in the performance goals letter released in October. Gisa Perez, FDA generi...
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    22 Case Studies Where Phase 2 and 3 Results Diverge: New FDA Report

    With a growing interest from industry in exploring alternatives to Phase 3 trials (ie. relying on different types of data and unvalidated surrogate endpoints), the US Food and Drug Administration (FDA) on Thursday released a new report documenting 22 different times drugs, vaccines and medical devices since 1999 saw promising Phase 2 clinical trial results that were not confirmed in Phase 3 trials. FDA says the report “is not intended to assess why each of these unexpect...
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    FDA Classifies Post-Concussion Test

    Months after clearing the first computer-based test intended to measure cognitive function after a suspected concussion, the US Food and Drug Administration (FDA) on Monday said it considers such devices to be Class II, or moderate risk devices. In August, FDA cleared ImPACT Applications' Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric devices via its de novo classification pathway, as no similar devices had been previously cl...