• 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, ...
  • 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 ...
  • Regulatory NewsRegulatory News

    FDA inspection turns up more problems for Philips Respironics

    Hundreds of thousands of complaints from users of Philips Respironics’ breathing assistance devices have been inadequately addressed by the firm, according to recent information released by the US Food and Drug Administration (FDA). The release of an inspection report and FDA’s accompanying statement provides more detail on what Philips knew, and what the firm did – or did not do – to remedy known problems with degradation of foam components in its breathing devices.   ...
  • Regulatory NewsRegulatory News

    Lilly 483 report offers insights from site making COVID antibodies

    The US Food and Drug Administration (FDA) on 12 August released a Form 483 report to Eli Lilly’s sterile injectables site in Indianapolis, noting multiple quality lapses.   The observations follow a February to March 2021 inspection at the site, which makes several medications: bamlanivimab and etesevimab for COVID-19, glucagon for treating severe hypoglycemia in diabetic patients, and ramucirumab for non-small cell lung cancer.   One of the seven observations wa...
  • Regulatory NewsRegulatory News

    FDA Sends Form 483s to Lupin, Aurobindo and Cipla Sites

    Following inspections in late September, India-based generic drugmakers Lupin, Aurobindo and Cipla received Form 483s posted last week by the US Food and Drug Administration (FDA) for observations related to cleanliness, investigations into out-of-specification results and other deficiencies. Lupin’s site in Tarapur, India was inspected over five days in late September, and the partially redacted 483 includes three observations. The first questions the company’s investi...
  • Regulatory NewsRegulatory News

    Novartis Blames Zolgensma Data Manipulation on Two Fired Senior Executives

    In its response to a US Food and Drug Administration (FDA) Form 483, Novartis said in a document released Tuesday that two senior executives at its subsidiary AveXis “could not offer a credible explanation for revisions to and inconsistencies in the data” and were later fired from their positions in August. The firings follow the revelation last month that AveXis manipulated some of the nonclinical data included in the biologic license application for its billion-dollar...
  • Regulatory NewsRegulatory News

    Power Failures Land India-Based Cancer API Manufacturer a Form 483

    Following a five-day inspection last month, the US Food and Drug Administration (FDA) sent a Form 483 to active pharmaceutical ingredient (API) manufacturer Shilpa Medicare Limited after the agency uncovered long-lasting power failures at the site. “During the walkthrough on 24 July 2019, three power failures occurred within the facility during a 15-minute interval and a back-up generator did not resume power,” FDA investigator Yvins Dezan wrote. And while reviewing aud...
  • Regulatory NewsRegulatory News

    Questions Pile up for Novartis as Senators Call on FDA to Take Action

    Why wait three months to tell the US Food and Drug Administration (FDA) about manipulated data? Why wait two months between documenting an initial issue and opening a nonconformance report (NCR)? And how harshly will FDA act? These questions and more are piling up for Novartis, following last week’s announcement that FDA is investigating the company for manipulating data linked to its $2.1 million gene therapy Zolgensma (onasemnogene abeparvovec-xioi). In Europe, regu...
  • Regulatory NewsRegulatory News

    FDA Warns Integra’s TEI Biosciences Over Contamination Issues

    A TEI Biosciences medical device facility drew an US Food and Drug Administration (FDA) warning letter earlier this month over failures to prevent bacterial contamination of certain manufacturing equipment and products. The warning letter, made public on Tuesday, cites four good manufacturing practice (GMP) violations for the manufacturer of collagen-based medical devices. The first three GMP violations cover a lack of procedures to control environmental conditions as w...
  • Regulatory NewsRegulatory News

    EU Taskforce of Pharma Regulators Issues its First Report on Big Data

    A European drug regulators’ taskforce on big data published its first report on Friday. The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) formed the HMA-EMA Joint Big Data Taskforce to harness the potential of data in development and oversight, starting with the new report. They examined clinical trial data, spontaneous adverse drug reports (ADRs), social media data and real-world data (RWD) to inform the work and reach “an important mileston...
  • Regulatory NewsRegulatory News

    CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations

    The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued draft guidance Friday to standardize a mechanism for a medical device establishment to request nonbinding feedback on actions such establishments propose to take to address an FDA Form 483. The draft standardized method has five parts. These relate to submitting a timely request—as defined by the agency—the statutory eligibility criteria, the device establishment’s ...
  • Regulatory NewsRegulatory News

    Updated: FDA Flags Pfizer’s Hospira Plant in Kansas Over Repeat 483 Citations

    A US Food and Drug Administration (FDA) inspection at the McPherson, KS plant of Pfizer’s Hospira business revealed seven repeat FDA Form 483 citations dating back to 2012. FDA investigators conducted an inspection of the human sterile drug manufacturing site from late July to early August 2018, with the agency posting the Form 483 to its website Friday. The latest 483 comes after Hospira’s Kansas plant drew an FDA warning letter last year, with significant violations...