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  • Feature ArticlesFeature Articles

    Preparing for an FDA Advisory Committee Approval Meeting

    This article discusses the nuances of FDA Advisory Committee approval meetings and provides an interpretive overview of what regulatory professionals need to know to prepare for a meeting. Introduction The US Food and Drug Administration (FDA) define an Advisory Committee simply as a group of external experts convened to offer advice to the agency. However, in realty, the practice is more complicated. In other places on its website, FDA states Advisory Committees can ...
  • Regulatory NewsRegulatory News

    Health Advocacy Groups Call for Changes to Priority Review Voucher Program

    A group of health advocacy organizations are calling on the Senate Committee on Health, Education, Labor and Pensions (HELP) to tighten requirements for obtaining priority review vouchers for drugs for tropical diseases. In a letter addressed to HELP Committee Chairman Lamar Alexander (R-TN) on Tuesday, seven organizations including Médecins Sans Frontières (MSF), Drugs for Neglected Diseases Initiative (DNDi), Center for Global Health Policy, TB Alliance, Treatment Acti...
  • Regulatory NewsRegulatory News

    FDA Defends Plans to Regulate LDTs at House Hearing

    The US Food and Drug Administration (FDA) is making it clear to Congress that it's up to the task of regulating lab developed tests (LDTs). Speaking at a House Energy & Commerce Committee hearing today, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH) defended the agency's plan saying, "Getting the right treatment to the right patient at the right time depends on having accurate, reliable and clinically validated tests." Unlike traditi...
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    Practices and Preferences of FDA Medical Device Advisory Committee Members

    This article describes, based on survey results, how Medical Device Advisory Committee members prepare for meetings and key factors influencing their thinking. For many Premarket Approval (PMA) submissions and supplements, a Medical Device Advisory Committee panel meeting is a required step toward product approval by the US Food and Drug Administration (FDA). In the last five years, the Center for Devices and Radiological Health (CDRH) has followed the advice of its co...
  • Regulatory NewsRegulatory News

    EMA Committee Finds No Link Between HPV Vaccines and Rare Conditions

    After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used." PRAC Review There are currently three centrally-authorized HPV vaccines in the EU – Gardasil/Silgard, Gardasil 9 and Cervarix – to protect against cervical cancer and other HPV related conditions. Upon...
  • 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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...