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  • Regulatory NewsRegulatory News

    Makena Withdrawal? A Look at the Timeline and Other Accelerated Approvals

    Earlier this week, an FDA advisory committee recommended that the agency withdraw Amag Pharmaceutical’s preterm birth drug Makena, a treatment that brought in more than $1 billion in sales before failing a confirmatory trial. The agency is now faced with the task of whether to take the committee’s vote and pull Makena from the market or allow it to remain until another confirmatory trial can be completed. Keeping Makena on the market would also present a rare situation,...
  • Regulatory NewsRegulatory News

    FDA Advisory Committee Calendar

    Regulatory Focus is pleased to team with Tarius , a regulatory information services provider, to routinely offer information about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner. Upcoming Meetings   13 September – Allergenic Products Advisory Committee   The committee will discuss and make recommendations on the safety and efficacy of Peanut [Arachis hypogaea] Allergen Powder manufactured by Ai...
  • RAPS' LatestRAPS' Latest

    13 Keys to a Successful FDA Advisory Committee Meeting

    When the US Food and Drug Administration (FDA) has significant questions or concerns about clinical data submitted in support of a product under review, it often seeks input from independent academicians and clinicians outside the agency. For this reason, FDA has established Advisory Committees comprised of such experts in various therapeutic areas. Currently, there are 49 such standing committees. If your company is a sponsor of a product subject to Advisory Committee rev...
  • Regulatory NewsRegulatory News

    When FDA and Advisory Committees Disagree: Study Investigates Gaps

    While only about one in five US Food and Drug Administration (FDA) new drug approvals or safety decisions run counter to outside advisory committee advice, a new study published Monday in the Milbank Quarterly looks further into what happens when both sides disagree. Of the 404 advisory committee meetings that involved voting questions (out of a total of 759 meetings between 2008 and 2015), the study looked at 376 meetings, with 271 (72%) for initial product approvals...
  • Regulatory NewsRegulatory News

    Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh

    A panel of outside experts convened by the US Food and Drug Administration (FDA) on Tuesday deliberated on available evidence and patient testimonies regarding the use of transvaginal mesh implants and advised the agency to consider adverse event reports when conducting premarket reviews. The panel, which was largely compromised of medical doctors, heard from patients who experienced a range of health complications following implantation of the surgical mesh. This marke...
  • Regulatory NewsRegulatory News

    FDA Advisory Committee Recommends Amgen-UCB Osteoporosis Drug

    With a final vote of 18-1, the bone, reproductive and urologic drugs advisory committee (BRUDAC) wrapped up a hearing on Wednesday with a recommendation that the US Food and Drug Administration (FDA) approve Amgen and UCB’s Evenity (romosozumab) osteoporosis treatment. The BRUDAC hearing on Wednesday marked Amgen and UCB’s second review for Evenity. The new recommendation comes after FDA issued a Complete Response Letter in July 2017 for the Biologics License Applicat...
  • Regulatory NewsRegulatory News

    Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System

    The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay. Although none of the comments and arguments for reducing the price of pharmaceuticals were new, panelists and senators even seemed to disagree on what exactly is causing prices in the US to be so much higher than the rest of the world. Mark Merritt, president of the Phar...
  • Regulatory NewsRegulatory News

    FDA Holds First Patient Engagement Advisory Committee Meeting

    The US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time on Wednesday and Thursday to give the agency input from  patients on clinical trials for medical devices. The meeting focused on a number of key issues related to clinical trials, with the goal of increasing patient input on trial design; patient recruitment, enrollment and retention; and communicating results back to patients. Patient Engagement at FDA FDA ...
  • Regulatory NewsRegulatory News

    FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing

    The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change. The hearing discussed a bill that would seek to undercut FDA’s oversight of a program, known as expanded access, whereby terminally ill patients and their doctors can request access to an investigational drug outside of a clinical trial. Right-to-Try laws have now passed in 37 states...
  • Feature ArticlesFeature Articles

    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...
  • Regulatory NewsRegulatory News

    Procedures for Device Advisory Committee Meetings: FDA Finalizes Guidance

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance from 2015 on advisory committee meetings. Background Other than the Medical Devices Dispute Resolution Panel (which this guidance does not address), there are 17 device panels: (1) Anesthesiology and Respiratory Therapy Devices; (2) Circulatory System Devices; (3) Clinical Chemistry and Clinical Toxicology Devices; (4) Dental Products; (5) E...
  • Regulatory NewsRegulatory News

    Researchers Find Most Expert Speakers at FDA ODAC Meetings Receive Sizable Industry Payments

    Experts speaking on behalf of a pharmaceutical company at US Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings often receive hefty sums, raising questions about the relationships between the companies and the experts ahead of three ODAC meetings next week. “We found that most (92.1%) expert speakers at FDA ODAC meetings receive sizable industry payments (median, $35,435). We were unable to establish payments made from the specific ...