• This Week at FDAThis Week at FDA

    This Week at FDA: User fee timeline, bivalent boosters, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest news out of FDA this week was the agency’s decision to recommend the inclusion of an Omicron BA.4/5 component in future booster doses in the first shift in strain composition away from monovalent vaccines targeting the prototype virus.   Alongside the recommendation, FD...
  • Regulatory NewsRegulatory News

    FDA tells Dutch API producer to clean up its equipment act

    A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the US Food and Drug Administration (FDA) dated 14 June. FDA found the presence of “visible powder residue” on non-dedicated equipment.   The warning letter pertained to Fagron Group B.V.’s manufacturing site in Saint Paul, MN. The company is headquartered in ...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    A handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely.   As of July 2022, those treatments include dexamethasone, Avigan (favilavir), Veklury (remdesivir) alone and in combination with Olumiant (baricitinib), Lagevrio (molnupiravir), Xevudy (sotrovimab), Regkirona (regdanvimab), Ronapreve (casirivimab and imdevimab), amubarvimab and romlusevimab (formerly BRII-196 and BRII-198), Actemra/RoActemra (tocil...
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    RAPS' LatestRAPS' Latest

    Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition

    Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to...
  • Feature ArticlesFeature Articles

    Supply chain disruptions: FDA guidance and temporary policies

    The COVID-19 pandemic caused one of the most prominent displays of supply chain disruption in the modern era. However, the US Food and Drug Administration (FDA) found ways to allow for regulatory flexibility by issuing guidance documents while still managing to protect consumers from adulterated and misbranded food.   Keywords – COVID-19 , FDA, food, guidance, pandemic, supply chain   Introduction The complexity of modern supply chains is never more eviden...
  • Feature ArticlesFeature Articles

    Proposed updates hint at dietary supplement legislative reform

    The dietary supplement industry has grown in the 28 years since the passage of the Dietary Supplement Health and Education Act (DSHEA), but the legislative reform has not been commensurate with those industry changes. This article discusses six key legislative updates proposed by FDA, industry, and consumer groups, suggesting reform is on the horizon for DSHEA.   Keywords – dietary supplement, Dietary Supplement Health and Education Act, DSHEA, CBD, hemp, listing, ...
  • Feature ArticlesFeature Articles

    Managing regulation of mental health-related claims in the COVID-19 era

    As we enter the third year of the COVID-19 pandemic, consumers are increasingly turning to dietary supplements to help them manage the daily stress of this unprecedented time. However, as demand for dietary supplements associated with stress and anxiety-reduction has increased, so has regulatory scrutiny from the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC). This article provides an overview of the FDA and FTC’s regulations and enforcement activ...
  • Feature ArticlesFeature Articles

    An update of China’s food safety regulatory framework

    This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formula, health foods (functional foods), and food for special medical purposes (FSMP). Introduction Since the melamine crisis in 2008, the overall food safety situation in China has been improved significantly. The first Food Safety Law w...
  • Regulatory NewsRegulatory News

    FDA calls for inclusion of Omicron BA.4/5 in future boosters

    Heeding the advice of its expert advisory committee, the US Food and Drug Administration (FDA) on Thursday recommended the inclusion of an Omicron BA.4/5 spike protein component in modified COVID-19 vaccine boosters for the upcoming fall and winter seasons.   The recommendation follows a 19-2 vote in favor of adding an Omicron-specific component to future boosters by FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) earlier this week. (RELATED:...
  • Regulatory NewsRegulatory News

    PFDD: Draft guidance seeks to demystify clinical outcomes assessments

    The US Food and Drug Administration (FDA) this week issued a sweeping draft guidance intended to help stakeholders incorporate patient experience data through the use of meaningful clinical outcome assessments (COAs). On 29 June, the FDA published a draft guidance titled, Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments . It’s the third in a series of four guidances the agency is developing to further ...
  • Regulatory NewsRegulatory News

    FDA approval lowers, but doesn’t eliminate disparities in immunotherapy use

    Racial, ethnic and sociodemographic disparities that are present in clinical trials and compassionate use agreements for cancer immunotherapy during the pre-approval period are reduced, but not eliminated after the US Food and Drug Administration (FDA) approves these cancer treatments, according to recent research published in JAMA Network Open .   “The time frame leading up to FDA approval is an important period in which to observe disparities,” Theresa Ermer, MD, of...
  • RoundupsRoundups

    Euro Roundup: MHRA plans wave of medtech regulation after consultation shows support for reform

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to introduce a wave of regulations to reclassify medical devices, strengthen postmarket surveillance and otherwise revise its approach to medtech after seeing support for reform in the 891 responses to its 2021 consultation.   MHRA proposed a slate of medtech reforms considering the Cumberlege Review and the opportunity presented by Brexit. The proposals were intended to improve patient safe...