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  • Feature ArticlesFeature Articles

    Mistake-Proofing the Workplace

    This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors. Introduction On his first job working for a large pharmaceutical company, one of the authors, Max Sherman, was responsible for th...
  • Regulatory NewsRegulatory News

    WHO Seeks Additional Birth Control API Manufacturers as US FDA Bans China Site

    A Chinese manufacturer of the active pharmaceutical ingredient (API) for the birth control drug levonorgestrel has been placed on the US Food and Drug Administration’s (FDA) import alert list, causing the World Health Organization (WHO) to scramble to find a replacement. "At the moment, there is no alternative levonorgestrel API which has been prequalified," WHO said Wednesday. When an API is prequalified by WHO, it can be used for the manufacture of finished pharmaceuti...
  • Regulatory NewsRegulatory News

    New Bill Directs FDA to Pull Bayer Birth Control Device

    In an unprecedented move, Rep. Michael Fitzpatrick (R-PA) on Wednesday unveiled a new bill that directs the US Food and Drug Administration (FDA) to withdraw from the market Bayer’s birth control implant Essure. The safety of the implantable device, which is used for permanent birth control, has been called into question recently, with FDA holding an advisory panel meeting on the device's safety in September. Rep. Rosa DeLauro (D-CT) also requested FDA pull the produc...
  • Fund to Provide for England's Thalidomide Victims

    • 21 December 2012
    This year marked two important anniversaries in the regulatory community. In the US, regulators noted the 50 th anniversary of the passage of the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act), a piece of legislation aimed at improving regulatory oversight over healthcare products. Worldwide, regulators marked a more ominous anniversary: 50 years since the drug Thalidomide was introduced to the world . The introduction of t...
  • FDA Plans to Review REMS, ETASU Strategies for Teratogenic Products

    The US Food and Drug Administration's (FDA) Drug Safety and Risk Management Advisory Committee (DSaRM) is preparing to meet in December to discuss risk management strategies for teratogenic products. Teratogens are most commonly pharmaceutical products which, when taken by a pregnant woman, can cause birth defects or other developmental abnormalities. One of the most notorious teratogens is Thalidomide, a drug used briefly in the 1950s and 60s to treat the effects of mor...
  • After 50 Years, Victims Finally Receive Apology from Thalidomide Manufacturer

    • 04 September 2012
    More than half a century after German drug manufacturer Grünenthal Group set into motion a new era of global drug regulation after its morning sickness drug Thalidomide was linked to deaths and serious birth defects, the company has offered something long sought by activists: an apology. Speaking at an unveiling of a Thalidomide Memorial in Rhineland, Germany, Grünenthal CEO Harald Stock offered his "sincere regrets" and "deep sympathy for all those affec...
  • Blaming FDA's Enforcement Discretion, Company Files for Bankruptcy

    Missouri-based KV Pharmaceutical , the manufacturer of pre-term birth prevention compound Makena (hydroprogesterone caproate injection), has filed for bankruptcy in federal court citing the US Food and Drug Administration's (FDA) "lack of enforcement" of the company's marketing exclusivity rights, reports Bloomberg . The filing could mark a final chapter in a long-running and often controversial saga between KV and FDA. The entire matter stems FDA's 2011 approva...
  • FDA: Challenge to Enforcement Discretion Without Standing, Merit

    Are the US Food and Drug Administration's (FDA) discretionary enforcement actions beyond industry reproach? In a recent court filing, lawyers for the US regulators argue they are, especially as discretionary actions-and statements of intended actions-relate to a specific court case filed by Minneapolis-based KV Pharmaceutical. In a July filing before the US District Court in DC , KV argued FDA had used enforcement discretion to "unlawfully" promote competition to its dr...
  • Pharmaceutical Manufacturer Sues FDA Over Use of Enforcement Discretion

    Minneapolis-based K-V Pharmaceutical has a problem: its flagship product, Makena, isn't maturing into the cash-generating product the company hoped it would become, leaving the company to face likely financial ruin if its cash-flow situation doesn't improve dramatically within the next few months. The company's hopes for dramatic change may rest squarely on the success of a lawsuit it filed on 5 June. Reuters reports the company has filed suit against the US Food and...
  • Sandoz Issues Recall After Packaging Errors Found

    Novartis AG subsidiary Sandoz announced on Wednesday, 6 June the initiation of a recall for ten lots of its oral contraceptive Intravole (levonorgestrel) after consumers notified the company of a packaging mix-up. Sandoz said the packaging error resulted in pills containing placebos being placed incorrectly within the blister packs, opening the possibility of consumers taking the oral contraceptives at the incorrect time. The blister packs ordinarily contain the placebo ...
  • Ireland: HIQA Releases Economic Evaluation of Repeat Universal Antenatal Screening for HIV in the Third Trimester of Pregnancy

    A report issued by Ireland's Health Information and Quality Authority (HIQA) contains advice on whether a change in the existing Irish guidelines for the management of human immunodeficiency virus-1 (HIV-1) in pregnancy is warranted. The conclusion is that the cost of introducing repeat universal antenatal HIV screening in the third trimester is high compared to the expected benefits. In the context of a finite healthcare budget, consideration must be given to the e...
  • New Safety Warning Issued For Popular Birth Control Product, Potentially Rekindling Controversy

    The US Food and Drug Administration (FDA) issued an updated safety warning 10 April about birth control products containing drospirenone-a synthetic version of the hormone progesterone-saying the hormone may be associated with a higher risk for blood clots than other progesterone-based pills. Some studies highlighted by FDA showed a three-fold increase in the risk of developing a blood clot, though FDA admitted "it is unclear whether the increased risk seen for blood clo...