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  • Regulatory NewsRegulatory News

    More Than 100 Days After Hurricane Maria, Drug Shortages Situation Expected to Improve

    The US Food and Drug Administration (FDA) on Thursday announced that shortages of IV saline are expected to improve early this year as Baxter – a leading producer of IV saline fluids – has said all its facilities on Puerto Rico have now returned to the commercial power grid. The good news on Baxter comes as the agency said all other companies that were on an initial list of drugs considered at risk of potential shortages – because the drugs were largely or entirely...
  • Regulatory NewsRegulatory News

    FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions

    The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV). In its MDUFA IV commitments, FDA agreed to tighter timelines to reach decisions for most medical device submissions in exchange for increased user fees and the introduction of a n...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Warns B. Braun Medical’s California Plant for Repeat Violations

    The US Food and Drug Administration (FDA) earlier this month sent a warning letter to B. Braun Medical’s Irvine, CA-based manufacturing facility for repeat violations also uncovered during inspections in 2013, 2014 and 2015. FDA found in its latest inspection from 18 April to 11 May 2016 that B. Braun’s "quality unit was not effectively exercising its responsibilities, particularly for investigating product defect complaints, manufacturing deviations, and adverse t...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Seeks Input on Device Accreditation Pilot

    The US Food and Drug Administration (FDA) on Monday asked stakeholders for input on its planned pilot program for accrediting medical device test laboratories in an effort to boost device makers' ability to rely on conformity to recognized standards to support premarket submissions. As part of the agency's negotiations with industry for reauthorizing the Medical Device User Fee Amendments (MDUFA) , FDA agreed to establish a program for accrediting test labs that evalu...
  • Regulatory NewsRegulatory News

    CDRH Plots Path to New 'Progressive' Approvals for Some Devices

    With a focus on how the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) can further use real-world evidence to inform its decision making, the center is considering "progressive" approvals whereby if a device comes to market in the EU before the US, it could also come to market in the US as long as additional postmarket data is submitted. Jeff Shuren, director of CDRH, speaking by teleconference at the MedCon conference in ...
  • Regulatory NewsRegulatory News

    Public Citizen Petitions FDA to Pull Some IV Solutions

    Consumer advocacy organization Public Citizen on Wednesday petitioned the US Food and Drug Administration (FDA) to immediately require the removal of hydroxyethyl starch (HES) intravenous (IV) solutions from the market because their risks outweigh their limited benefits and there are other, safer alternative IV solutions. According to the petition, there are two main categories of IV solutions: crystalloid and colloid. Colloidal solutions, including HES, have largely the...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Lead MDUFA Negotiator Details Changes in MDUFA IV Financing

    The US Food and Drug Administration's (FDA) top negotiator for the fourth iteration of the Medical Device User Fee Act (MDUFA IV) presented changes to the funding mechanisms of the program at a public meeting at FDA's White Oak Campus on Wednesday. Last week, FDA released its draft recommendations for changes to its user fee program for medical devices which would allow the agency to collect roughly $999.5 million— an increase of $320 million over the previous five-yea...
  • Regulatory NewsRegulatory News

    Final FDA Rule Clarifies Pharma Patent Process With Aim of Reducing Unnecessary Litigation

    With the intent to cut back on the type of litigation that can delay the approval and marketing of generic drugs under 505(b)(2) applications and abbreviated new drug applications (ANDAs), the US Food and Drug Administration (FDA) on Wednesday released a final rule that revises and clarifies its regulations on a number of different parts of the pharmaceutical patent process. The 289-page final rule amends FDA’s regulations to facilitate better compliance with and enforce...
  • Regulatory NewsRegulatory News

    FDA: Toxicity Seen in Fatal French Study Does Not Extend to Other FAAH Inhibitors

    The U.S. Food and Drug Administration (FDA) on Friday said that after reviewing the safety information of a first-in-human clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January, the agency found that the toxicity exhibited in the trial does not extend to other drugs in the class, known as fatty acid amide hydrolase (FAAH) inhibitors. Working alongside the European Medicines Agency (EMA) and ...