• Regulatory NewsRegulatory News

    FDA Analyst Counters Critiques of Orphan Drug Act

    While recent reports have claimed that drugmakers are manipulating the incentives provided by the Orphan Drug Act , Mike Lanthier, an operations research analyst at the US Food and Drug Administration (FDA), says that in most cases, the act is working as intended. "My sense is that the Orphan Drug Act has been a successful catalyst for spurring rare disease development," Lanthier said at the National Organization for Rare Disorders' (NORD) Summit in Washington, DC on ...
  • Regulatory NewsRegulatory News

    CDRH Clarifies Process for Consensus Standard Recognition Requests

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) this week detailed changes to its process for handling requests for the agency to recognize new voluntary consensus standards for medical devices, as required by the 21st Century Cures Act . Medical device makers often rely on consensus standards in the development and testing of their products, and FDA allows device makers to submit a declaration of conformity to show that the...
  • Feature ArticlesFeature Articles

    Navigating the Medical Device User Fee Act (MDUFA)

    This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations. 1 Introduction The category "medical devices" encompasses a wide variety of products intended for diagnosing diseases or other conditions as well as the cure, mitigation, treatment or prevention of disease. 2 Among its responsibilities, the US Food and D...
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    Senate Democrats to Trump: HHS Cuts Will Impede 'Cures' Implementation

    Eleven Senate democrats sent a letter to President Donald Trump on Tuesday explaining how his proposed cuts in the FY 2018 budget for the Department of Health and Human Services (HHS) will make implementation of the bipartisan 21st Century Cures Act much more difficult. "We urge you to listen to both sides of the aisle and drop any attempts to implement the damaging proposed cuts at HHS laid out in your budget," they wrote. Trump’s budget blueprint for 2018 ...
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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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    House and Senate Revive Bill Targeting Generic Drug Delays

    Leaders of the Senate and House Judiciary Committees, led by Sen. Patrick Leahy (D-VT), on Thursday re-introduced legislation to combat anticompetitive practices that can block the market entry of lower-cost generic drugs.  Known as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, the resurrected bill targets sample sharing (when brand-name drugmakers prevent generic firms from obtaining samples of the branded products so the generic ...
  • Feature ArticlesFeature Articles

    The Prescription Drug User Fee Act (PDUFA): A Primer

    This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process. Introduction: Benefits Offered by PDUFA When planning a New Drug Application (NDA) or other type of marketing application, regulatory professionals must consider many things. These considerations include: when the data will com...
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    Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire

    Leaders from the biopharmaceutical industry lobby and a patient advocacy group on Wednesday urged members of the House Energy and Commerce Committee to reauthorize the sixth iteration of the Prescription Drug User Fee Act ( PDUFA VI). And, in her second straight day of testimony on user fees before Congress, Janet Woodcock, director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) detailed how the agency's ability to...
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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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    Law Firm Challenges FDA on Combination Product Appeals

    Healthcare law firm Epstein Becker & Green (EBG) is calling on the US Food and Drug Administration (FDA) to improve how it handles challenges to its designation decisions for combination products. In a citizen petition sent to FDA last week, the firm says that lengthy delays for such appeals negatively affects both product sponsors and patients by delaying the launch of new combination products. Background Combination products, or products that combine two or more diff...
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    GAO: Drugmakers Want More Clarity on Antibiotic Incentives

    Despite some improvements, drugmakers say the US Food and Drug Administration (FDA) has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office (GAO). Specifically, GAO says that FDA has issued 14 updated or new guidances focused on antibiotics since the Generating Antibiotic Incentives Now (GAIN) Act was passed as part of the Food and Drug Admi...
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    House Bill Would Incentivize Drugmakers to 'Repurpose' Drugs for Rare Diseases

    Rep. Gus Bilirakis (R-FL) on Monday reintroduced a bill that would grant drugmakers an additional six months exclusivity for repurposing already-approved drugs to treat rare diseases. The bill, known as the Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act , was initially included in the 21st Century Cures Act , but was removed before it was signed into law last year. The additional exclusivity for new orphan indications under the OPEN Act w...