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    FDA Enforcement Trends for Broadcast Advertisements

    This article presents recent FDA enforcement trends related to broadcast advertisements and explains how regulatory professionals can approach the review and approval of promotional materials. The article also provides a review of relevant FDA authorities and guidance, as well as practical takeaways for industry with a focus on product ads appearing on TV or YouTube that may distract viewers from important risk information. Introduction From January 2016 through Augus...
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    CDRH Plots Creation of New 'Super Office,' Alternative 510(k) Pathway

    Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told attendees at the final session at AdvaMed’s MedTech conference in San Jose, California, that his center is plotting the creation of a new "super office." The so-called "Total Product Life Cycle 'Super' Office" will integrate premarket, postmarket surveillance and quality-compliance functions, Shuren said, noting it will be "a big deal." The o...
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    FDA Warns Drugmaker Over Opioid Marketing Materials

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has warned Canadian drugmaker Cipher Pharmaceuticals over promotional materials for its combination immediate and extended release opioid ConZip (tramadol hydrochloride). The warning letter, only the second sent from OPDP in 2017, comes as the US grapples with an ongoing opioid epidemic that has brought increased scrutiny on opioid makers and their marketing practices. According to ...
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    OPDP Study Raises Questions About the Balance of Information in Mobile Ads

    A new study by officials from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) raises questions about the balance of benefit and risk information in mobile ads for prescription drugs. As with other mediums for drug advertising, including print, television, web and social media, the study finds that mobile ads tend to present the benefits of drugs more prominently than their risks. "This echoes prior research across a broad range o...
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    Asia Regulatory Roundup: India’s DCGI Asks Industry How to Further Cut Regulatory Burdens (5 July 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Asks Industry How to Further Cut Regulatory Burdens DCGI Dr. GN Singh has asked the industry how his agency can further reduce the regulatory burden companies face. Singh put out the call for suggestions about how DCGI can streamline drug regulation as part of a release detailing the changes it has already made to make it easier to do business in India. The ind...
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    GAO: FDA Needs a Plan for GDUFA Carryover Fees

    As Congress looks to reauthorize the US Food and Drug Administration's (FDA) user fee programs, the Government Accountability Office (GAO) on Monday released a report saying that FDA should develop a plan for managing unspent fees collected from generic drugmakers. "Such a documented plan could aid Congress in determining the appropriate amount of user fees to be collected by the agency during the annual appropriations process and when considering a reauthorization of th...
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    Industry Supports FDA Proposal to Create New Office of Patient Affairs

    Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs. The idea for the new Office of Patient Affairs (OPA), proposed in March , is part of the agency’s efforts to offer "a single, central entry point to the Agency for the patient community," as well as "triage and navigation services for inbound inquir...
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    Asia Regulatory Roundup: India Sets Guidelines for Fixed-Dose Combination Trials (13 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Sets Guidelines for FDC Trials as Long Wait for Phase IV Protocols Continues The Drug Controller General of India (DCGI) has outlined how makers of fixed-dose combinations (FDCs) can meet regulatory demands for clinical data on their drugs. DCGI Dr. GN Singh is asking FDC manufacturers to focus on safety data and is providing flexibility in the design of clinical...
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    US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval

    The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars. The case, pitting biologics manufacturer Amgen against Novartis subsidiary and biosimilar manufacturer Sandoz, attempted to clarify what’s known as the biosimilars "patent dance," which is the process by which companies must exchange and figure out the pa...
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    Asia Regulatory Roundup: CFDA Offers New Drug, Device Draft Guidance (16 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Shares Flurry of Proposals to Encourage Drug, Medical Device Innovation The China Food and Drug Administration (CFDA) has released four draft documents intended to encourage innovation in the drug and medical device industries. CFDA’s proposals aim to cut the time it takes to set up a clinical study, accelerate the approval process, overhaul the patent system and...
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    FDA Launches New ORA Structure to Align Inspections With Expertise

    The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA). The move, part of FDA's program alignment , is aimed at more closely aligning the agency's inspection efforts with the various products it regulates. "Specializing by FDA-regulated product type more closely mirrors the organizational model of FDA's centers and the industries we regulate," FDA writes. Under the agency's previo...
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    FDA Official Highlights Foreign Supply Chain Challenges

    Drugmakers should be mindful of the risks involved with relying on foreign manufacturers as part of their supply chain, said Thomas Cosgrove, director of the US Food and Drug Administration's (FDA) Office of Manufacturing Quality within the Center for Drug Evaluation and Research. Speaking at the Food and Drug Law Institute's annual conference on Friday, Cosgrove detailed some of the biggest challenges drugmakers face when contracting with foreign manufacturers, which fi...