• Regulatory NewsRegulatory News

    European Commission Revises Q&A on Safety Features for Medicinal Products

    The European Commission on Monday released a revised question and answer document regarding the implementation of the rules on the safety features for medicinal products for human use. Revisions in the document are related to two questions and answers, including one on if a pack bearing safety features is lawfully opened by, for instance, parallel traders or manufacturers replacing the leaflet, can the pack be resealed? The answer notes that in certain circumstances it ...
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    FDA Delays Implementing Parts of 'Intended Use' Rule

    Confusion and concerns over portions of a tobacco-related final rule have pushed the US Food and Drug Administration (FDA) to delay indefinitely the implementation of the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used. "This is a determination that can have significant implications for, among other things, how manufacturers communicate about and promote their products. How we determi...
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    FDA Offers Recommendations on Highlights Section of Labeling

    The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations on completing certain portions of the Highlights section of labeling for prescription drugs and biologics. Specifically, the guidance details the content and format of the Product Title and Initial US Approval subsections within the Highlights of Prescribing Information for newly approved drugs and drugs with labels being revised. In 2006, FDA's final rule on the conten...
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    FDA Plots Policy Priorities for 2018

    The US Food and Drug Administration (FDA) on Thursday announced its priorities for policy activity in 2018, which will include reducing the misuse and abuse of opioids, promoting generic drug and biosimilar competition, creating a total product lifecycle office for medical devices, advancing digital health technologies and strengthening the agency’s workforce. “Our work is taking place during an inflection point in both science and policy,” FDA Commissioner Scott Go...
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    Trial Transparency: NIH Says Final Rule From 2017 has Helped

    Almost a year ago, the National Institutes of Health (NIH) made effective a new policy to better disseminate information from NIH-funded clinical trials through ClinicalTrials.gov, and the agency says that so far, it’s seen some improvements. Back in 2007, section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) established a requirement that "applicable clinical trials" must be registered and information must be submitted to Clinicaltrials.gov. ...
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    Ruling Against Novartis Could Have Wider Implications for Generic Drug Labels

    California's Supreme Court on Thursday ruled against Novartis in a decision that could have wider implications for whether brand-name or generic drugmakers should be held liable for warning consumers of risks in their drug labels. In a departure from other recent rulings, the highest California court found that a brand-name drug manufacturer's duty to warn consumers does extend to a generic, but only because federal regulations currently require generic drugs to carr...
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    FDA Bars Use of 24 Ingredients in Antiseptic Washes

    The US Food and Drug Administration (FDA) on Tuesday finalized a rule barring the use of 24 active ingredients, including triclosan, from use in over-the-counter (OTC) antiseptic washes and rubs such as hand washes and surgical hand scrubs used in health care settings. The rule was first proposed in 2015 , and finalizes a 1994 tentative final monograph for OTC antiseptics as amended by the 2015 proposed rule. "Ensuring the safety and effectiveness of over-the-counter h...
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    FDA Issues Delayed DSCSA Grandfathering Guidance

    The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing its policy for when packages and homogenous cases of drugs without a product identifier are grandfathered from certain provisions of the Drug Supply Chain Security Act (DSCSA). While the guidance comes two years after the deadline set by the DSCSA and on the same day that requirements for manufacturers to begin affixing or imprinting product identifiers on packages and homogenous cases ...
  • Feature ArticlesFeature Articles

    Medical Product Communications Consistent With FDA-Required Labeling Draft Guidance: Navigating the Gray Zone

    This article discusses the changing landscape for promotional review regarding the shift in evidentiary standards introduced in the 2017 Draft Guidance. It also highlights industry perspectives for consideration to companies looking to apply the principles outlined in the Draft Guidance or in preview to what could be addressed in a future revision. Introduction Regulatory advertising and promotion professionals are accustomed to working amidst ambiguity or in the gray...
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    Updated: FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents

    The US Food and Drug Administration (FDA) on Thursday released new draft guidances for 32 drugs, including for those companies looking to develop generic versions of Mylan’s EpiPen (epinephrine) alternative Adrenaclick, Novartis’ cancer treatment Afinitor (everolimus) and AstraZeneca’s cancer treatment Lynparza (olaparib). On top of the new drafts, FDA released 19 revised guidance documents, including one for companies looking to develop generics of Eli Lilly’s er...
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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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    Conducting a Successful Advertising and Promotion Review of Restricted Medical Devices

    This article provides insight for regulatory professionals regarding developing a successful advertising and promotional review of restricted medical devices. It demonstrates how medical device manufacturers and pharmaceutical companies can improve communication and collaboration between regulatory and marketing to streamline and improve the compliance review process for promotional materials and achieve an effective marketing strategy. The Dance "How small can I make...