• Feature ArticlesFeature Articles

    January’s Regulatory Focus: The impact of disruption on the global regulatory community

    Feature articles during January focused the effects of disruption on global regulatory practice. In context of the COVID-19 pandemic, authors examined expedited approval pathways for test kits in southeast Asian countries; the role of digital promotional strategies in minimizing the impact of the pandemic on advertising, promotion, and labeling; and the importance of continuing soft-skills training during remote working. Under the broader framework of disruption, a group o...
  • Feature ArticlesFeature Articles

    Transforming regulatory strategy to meet the evolving compliance landscape

    Changes in industry regulations are now viewed as one of the top three disruptive business trends facing pharmaceutical and life sciences organizations today. These same pressures are extending to the medical device market. In this article, the authors explore how perception of regulatory compliance is evolving due to a variety of driving forces. They outline the role digital transformation can play in helping pharmaceutical companies meet new regulatory compliance demands...
  • Feature ArticlesFeature Articles

    MDR, IVDR, and compliance: A guide for distributors

    Distributors must prepare for new incoming requirements under EU medical device and in vitro diagnostic device regulations. The importance of establishing an effective quality management system, drafting comprehensive contractual agreements and, if required, engaging notified bodies, has created much uncertainty for distributors. To fulfil these new requirements and maintain device supply chains, it is essential for distributors to act early, ensure sufficient in-house com...
  • Feature ArticlesFeature Articles

    Dietary supplement class actions: Recent overlap with traditional FDA enforcement

    This article provides an overview of class action lawsuits targeting the dietary supplement industry. Recent trends indicate that companies should look beyond regulatory compliance and consider how a “reasonable consumer” would interpret claims in labeling, even claims that comply with FDA requirements. There are also important steps companies can take to prevent these lawsuits, as well as defenses that courts seem increasingly willing to accept. By staying aware of the cl...
  • 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

    EU Restricts Slovak Manufacturer’s GMP Certificate Over Spate of Deficiencies

    Unimed Pharma, a Slovakia-based pharmaceutical manufacturer, drew a statement of noncompliance after an inspection revealed two critical and 21 major good manufacturing practices (GMP) deficiencies. The statement of noncompliance took issue with the firm’s manufacturing operations for sterile products, including aseptically prepared small volume liquids and batch certification. The statement was issued by the Slovakian State Institute for Drug Control (SIDC), following ...
  • Regulatory NewsRegulatory News

    Health Canada Details Medical Device Action Plan

    Health Canada issued a new action plan on Thursday, detailing a three-part strategy intended to improve safety, oversight and quality in the Canadian medical device ecosystem.   The move follows on the heels of an International Consortium of Investigative Journalists investigation into patient harm linked to surgically implanted medical devices. The investigation  prompted  the Canadian Minister of Health to call on Health Canada to address premarket approval processes...
  • Regulatory NewsRegulatory News

    CDRH Touts Uptick in Foreign  Device Inspections

    The US Food and Drug Administration (FDA) saw a 243% spike in the annual number of foreign medical device inspections conducted by agency officials since 2007, according to a new report.   “As medical device manufacturing has become an increasingly global enterprise, the FDA has taken forceful action to increase inspections of medical device firms, especially those located in foreign countries,” said Jeff Shuren, director at the FDA’s Center for Devices and Radiologi...
  • Regulatory NewsRegulatory News

    Mylan Discontinues, Transfers Products In Wake of FDA Warning Letter

    A recently issued US Food and Drug Administration (FDA) warning letter escalated previously observed issues around quality control at Mylan Pharmaceuticals’ manufacturing facility in Morgantown, WV, to significant violations of good manufacturing practices (GMP).   The warning letter posted on Tuesday took issue with the firm’s May response to the 13 inspectional citations outlined in a Form 483, following an inspection conducted by FDA investigators between March an...
  • Regulatory NewsRegulatory News

    FDA Dings Surgical Instrument Manufacturer Over 'Unacceptable' Timelines

    American Contract Systems provided “unacceptable” timelines to correct US Food and Drug Administration (FDA) inspectional citations, according to a new FDA warning letter.   The Pennsylvania-based manufacturer of surgical trays and kits indicated for hospital use drew a total of five significant violations, following the quick turnaround on the warning letter. FDA investigators inspected the firm’s manufacturing facility in Zelienople over the course of two weeks from ...
  • Regulatory NewsRegulatory News

    FDA Warns BD for GMP Violations at Lock Flush Syringe Facility

    The US Food and Drug Administration (FDA) has warned medical device maker Becton Dickinson (BD) for good manufacturing practice (GMP) violations at the company’s Franklin, Wisconsin facility.   The warning letter comes after two-and-a-half-month inspection this summer during which FDA found the company’s pre-filled heparin lock flush syringe and pre-filled 0.9% sodium chloride lock flush syringe products to be adulterated.   The warning is BD’s second in 2018 after...
  • Regulatory NewsRegulatory News

    FDA Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts

    The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C. Becky Wood, chief counsel for FDA, keynoted the conference and discussed the opioid crisis, and in particul...