• Feature ArticlesFeature Articles

    March's Regulatory Focus: Regulatory intelligence

    Feature articles during March focused on regulatory intelligence (RI), including first-hand accounts of setting up a dedicated process for RI monitoring and developing an in-house RI database, as well as an examination of the implications of the US Food and Drug Administration’s (FDA’s) new integrated review template for RI. Also included were articles on the importance a global unique device identification (UDI) system, the FDA’s Bad Ad program, and the importance of writ...
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    Special Counsel raises questions about FDA’s biologics inspections

    In closing a whistleblower case concerning allegations of downgraded inspection findings raised by a former investigator on the US Food and Drug Administration’s (FDA) Team Biologics, US Special Counsel Henry Kerner wrote to President Joe Biden that he is “troubled” by many aspects of the case.   In the letter, Kerner says that FDA’s report on its investigation of the allegations “meets all the statutory requirements but that the findings do not appear reasonable” and ...
  • Feature ArticlesFeature Articles

    The FDA, prescription drug promotion, and its Bad Ad Program

    This article discusses pharmaceutical industry promotion for prescription drugs. The author provides an overview of the regulatory landscape from the US Food and Drug Administration’s (FDA) perspective followed by a discussion of the FDA’s Bad Ad Program which celebrated its ten-year anniversary in the summer of 2020. FDA's Bad Ad Program is an outreach program designed to help healthcare providers (HCPs) recognize and report potentially false or misleading prescription d...
  • RoundupsRoundups

    FDA Approvals Roundup: Abecma, Vyxeos, Myrbetriq

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Abecma cleared as first cell-based gene therapy for multiple myeloma in adults Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) has been approved for treating relapsed or refractory multiple myeloma in previously treated adults, making it the first FDA-sanctioned cell-based gene therapy for this condition.   Abecma is a B-cell maturati...
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    FDA warns Florida firm for GMP, QS violations

    In a lengthy warning letter issued to Tarmac Products, Inc, a Florida-based contract manufacturer, the US Food and Drug Administration (FDA) cites the company for a dozen good manufacturing practice (GMP) and quality system (QS) violations.   The warning letter, first published Tuesday, was sent last November based on issues observed during a two-and-a-half-week inspection in September 2019, several of which are repeat observations from previous inspections in 2015 and...
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    HHS proposes updates to patient labeling, BA/BE study regulation

    The US Department of Health and Human Services (HHS) has released its semiannual inventory of proposed rulemaking actions, with a relatively brief to-do list for drug and medical device regulators.   For the US Food and Drug Administration (FDA), actions sitting at the proposed rule stage include an amendment to 21 CFR 320 to clarify FDA’s expectations for the conduct of analytical and clinical pharmacology as well as bioavailability and bioequivalence studies to suppo...
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    Clinical trial diversity: FDA pushes real-world evidence, diffusion of trial sites

    Real-world evidence, post-marketing studies, and migrating clinical trial sites into underserved communities are all strategies the U.S. Food and Drug Administration (FDA) is pushing to help increase data on the outcomes of minority patients, according to Amy Abernethy, MD, PhD, the agency’s principal deputy commissioner.   “There is real a gap between the makeup of our American public and the representation of our Black community and Black women in clinical trials,” A...
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    FDA, unmoved by new meta-analysis, still recommends Makena withdrawal

    The US Food and Drug Administration is standing by its October 2020 recommendation that Makena (intramuscular17-hydroxyprogesterone caproate, or 17-OHPC) be withdrawn from the market, notwithstanding a new meta-analysis of the efficacy of progestogens for prevention of preterm birth.   In a long-awaited Lancet publication , members of the Evaluating Progestogens for Preventing Preterm birth International Collaborative (EPPPIC) research team found that both vaginal pr...
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    FDA okays first-in-world valve to address congenital heart disease

    The US Food and Drug Administration (FDA) announced Friday that it approved a first-in-world device to address pulmonary valve regurgitation in patients with some kinds of congenital heart disease, along with a device meant to help gait problems in people with multiple sclerosis.   The Harmony Transcatheter Pulmonary Valve (TPV) system is a less invasive option than open-heart repair for severe pulmonary valve regurgitation in patients with a native or surgically repai...
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    FDA increases OTC monograph facility fees in reissued notice

    Following a dispute with the Department of Health and Human Services (HSS) that resulted in its initial notice being withdrawn, the US Food and Drug Administration (FDA) on Thursday reissued its notice announcing fee rates for its newly created over-the-counter (OTC) monograph drug user fee program (OMFUA) for FY2021.   FDA initially issued the notice on 29 December, but it was quickly withdrawn by HHS over public outcry against FDA’s plans to collect user fees fro...
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    Can older adult clinical trial participation be boosted?

    The US Food and Drug Administration on Tuesday convened leaders from the agency, industry and academia to tackle barriers and solutions to enrolling older adults in clinical trials. Highlights of the virtual public workshop included solid data from FDA showing the mismatch between disease prevalence and age representation in clinical trials, as well as an in-depth examination of how older adults were represented in COVID-19 vaccine trials.   S. W. Johnny Lau, PhD, a ...
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    FDA issues 36 new and revised product-specific guidances

    The US Food and Drug Administration (FDA) this week issued 36 new and revised draft product-specific guidances meant to facilitate the development of generic drugs by clarifying the agency’s expectations for the studies required to demonstrate bioequivalence (BE) to a reference listed drug (RLD).   The latest batch of guidances includes 22 new and 14 revised draft guidances covering drugs to treat prostate cancer, hepatitis C, multiple sclerosis and numerous other cond...