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  • 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...
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    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

    OPQ Reports on State of Drug Quality in FY2018

    In a report released Monday, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) provides a look at the pharmaceutical quality landscape for drugs and biologics intended for the US market.   The report itself breaks down different metrics related to product quality and manufacturer compliance with current good manufacturing practice (cGMP) to paint a picture of the overall pharmaceutical quality landscape.   While FDA reports an overa...
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    FDA to Survey Healthcare Professionals on Prescription Drug Marketing

    The US Food and Drug Administration (FDA) on Friday announced it will go ahead with a survey of healthcare professionals (HCPs) on how they are impacted by prescription drug promotion aimed at a professional audience.   The announcement comes after the agency consulted on its plans for  the survey in March 2018 and follows two earlier surveys that looked at HCPs’ attitudes toward direct-to-consumer (DTC) advertising. The survey will also include questions about HCPs’...
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    FDA Touts Quality Office’s Achievements in 2018

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Thursday released its 2018 annual report touting its accomplishments in a year that saw record numbers of new and generic drug approvals.   OPQ is the office responsible for quality assessments for investigational new drug applications (INDs) and all marketing applications reviewed by the Center for Drug Evaluation and Research (CDER), including new drug applications (NDAs), abbreviat...
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    FDA Names New Office of Generic Drugs Director

    In an email to staff on Tuesday, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced that Sally Choe will take over for Kathleen Uhl as Director of the Office of Generic Drugs (OGD) upon Uhl’s retirement at the end of the month after serving more than 20 years at the agency.   “With more than 18 years of experience in global drug development, Sally is an accomplished leader in both governmen...
  • 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 ...
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    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...
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    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...
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    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 ...