• Feature ArticlesFeature Articles

    Evolution of Advertising and Promotion Review Systems

    This article addresses the evolution of review systems used for advertising and promotion materials. Promotional review and approval, at its root, is designed to ensure all marketing and sales materials for pharmaceuticals are compliant with established legal, regulatory and medical standards, as well as company policies and procedures. Pharmaceutical companies employ cross-functional teams applying standard principles of education and training and good judgment to eva...
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    Stories From the Promotional Review Battlefront

    This article shares advertising and promotion experiences and presents strategies to improve a team's performance. It was the best of times, it was the worst of times… sounds like an ad/prom review team meeting. Many companies have a cross-functional team responsible for reviewing and approving advertising and promotional materials. This team and their meetings are known by many names: Promotional Review Committee (PRC), Medical/Legal/Regulatory (MLR), Medical/R...
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    Do Public Hearing Participants Influence Outcomes of FDA Advisory Committee Meetings?

    This article discusses the importance of the open public hearing portion of an FDA Advisory Committee meeting. Many regulatory changes have impacted the US Food and Drug Administration (FDA) approval process for new drugs and medical devices, including the requirement from the Food and Drug Administration Amendments Act for an Advisory Committee review. Advisory Committees provide the agency with advice from outside experts on issues related to drugs, biological prod...
  • Regulatory NewsRegulatory News

    Two-Day FDA Advisory Committee Meeting to Address Drug Compounding Questions

    The US Food and Drug Administration (FDA) will host a two-day public advisory committee meeting on 27 and 28 October to look into updating a list of bulk drug substances that should not be compounded, and another list of substances that can be compounded. Background The  Drug Quality and Security Act (DQSA)  of 2013 was passed in the wake of a deadly outbreak of fungal meningitis caused by  deficient compounding practices  at a Massachusetts-based company. Historicall...
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    FDA’s CDRH Unveils First-Ever Patient Engagement Advisory Committee

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Friday announced the establishment of the first-ever Patient Engagement Advisory Committee (PEAC) to ensure patient needs and experiences are included during the review of medical devices. The committee, which will be made up of nine voting members, one non-voting industry representative and one non-voting consumer representative, will bring together patients, patient a...
  • Regulatory NewsRegulatory News

    EMA Announces Sweeping Overhaul of Pediatric Class Waivers

    In a major move, the European Medicines Agency (EMA) announced today it is revoking or revising most product class waivers that allow companies to bypass the requirement to test new drugs in pediatric populations before they can be authorized. Background Companies are often reluctant to conduct clinical studies in children over ethical concerns and fear of adverse events occurring during trials. These reservations have created a gap in the number of products authorized ...
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    What's in Store for the Medical Device Tax?

    Last month, the US House of Representatives passed a bill that would repeal the medical device tax levied under the Affordable Care Act ( ACA ). Now, the Senate Joint Economic Committee (JEC) has released a report critical of the tax, calling the tax "onerous" and "poorly conceived." Background The medical device tax has been controversial since before ACA was signed in 2010. Under ACA , a manufacturer or importer of a medical device is subject to an excise tax of...
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    EMA Reflects on Advanced Therapy Classification

    The European Medicines Agency (EMA) has released a new reflection paper discussing how products are classified as advanced therapy medicinal products (ATMPs). Background In the EU, medicinal products derived from genes, cells or tissues are classified as ATMPs. Because these areas of biomedicine are still in early stages of development and are fundamentally different from other types of medicine, the European Commission (EC) regulates them differently. ATMPs are define...
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    FDA Considers Compounding Restrictions on Four Drugs, Including Acetaminophen

    The US Food and Drug Administration (FDA) is preparing to ask one of its newest advisory committees to decide if some compounding pharmacies should be allowed to make four drugs, including the widely used painkiller acetaminophen. Background The advisory committee, known as the Pharmacy Compounding Advisory Committee (PCAC) , was re-created under a piece of 2013 legislation known as the  Drug Quality and Security Act (DQSA) . The law, passed in the wake of a major drug...
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    What Influences CDER Advisory Committee Members?

    Over the past two decades, the US Food and Drug Administration’s (FDA’s) Center for Drug and Evaluation and Research (CDER) has been developing new, expedited pathways to help bring innovative medical products to market more efficiently. These pathways include fast track designation, accelerated approval, priority review and, more recently, breakthrough therapy. Through these expedited pathways, some products have been approved with fewer clinical data than traditio...
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    Marketing Exclusivity Provisions for Rare Disease Drugs Back in 21st Century Cures Bill

    An updated draft of the House Energy and Commerce (E&C) Committee's 21st Century Cures Act has reintroduced a provision which would extend marketing exclusivity for some drugs repurposed to treat rare diseases or conditions by six months. Background The provision, popularly known as the Orphan Product Extensions Now Act , was originally introduced in the US House of Representatives in November 2014. Under the bill, existing pharmaceutical products would be grant...
  • Regulatory NewsRegulatory News

    Following Negative Comments by Reviewer, EU Committee OK's Gene Therapy

    Last month, German regulators postponed their review of UniQure's gene therapy Glybera after the European Medicines Agency (EMA) rapporteur assigned to the product claimed new data showed Glybera lacked efficacy and called for it to be reassessed . Now, EMA's Committee for Advanced Therapies (CAT) has completed its assessment, and is maintaining its positive opinion of Glybera, Reuters reports. Background Glybera is the first gene therapy approved for use in the E...