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  • Regulatory NewsRegulatory News

    FDA Warns Massachusetts PET Drug Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Woburn, Massachusetts-based PETNET Solutions Inc. after an inspection last spring uncovered unclean conditions and failures in environmental monitoring for the positron emission tomography (PET) drug manufacturing site’s aseptic operations. The letter notes that the FDA inspector “observed a state of disrepair and lack of cleanliness” at the site, while “sporeforming fungi were repeat...
  • FDA: State, Federal Efforts to Reduce Access to Zohydro 'Extremely Troubling'

    Since the US Food and Drug Administration (FDA) approved Zogenix's non-abuse-deterrent pure hydrocodone painkiller Zohydro ER (hydrocodone bitartrate) in October 2013, groups opposed to the drug have proposed a number of ways to overrule the agency's approval order and remove the drug from the market. Legislators have called for FDA to reconsider. They've called for the government to investigate the approval. They've called for the Department of Health and Human Services...
  • Compounding Pharmacy Recalls Continue as FDA Inspection Finds Still More Deficiencies

    A steady drumbeat of recalls from compounding pharmacies has struck a note for the third time in approximately a week, with Massachusetts-based Pallimed Compounding Pharmacy issuing a notice indicating that all sterile products manufactured at the facility should be recalled and not used after an inspection by the US Food and Drug Administration (FDA) indicated deficiencies. In a statement, the company said it had not been made aware that any compounded product made by i...
  • Massachusetts Regulators Discover Widespread Failings at Sterile Manufacturing Sites

    • 05 February 2013
    Crises are rarely ones of regulators' own choosing. So in 2012 when pharmaceutical compounding became the topic de jure after a massive outbreak of fungal meningitis, state and federal regulators seemed blindsided, and were scrambling not only to trace the outbreak to its point of origin, but also to answer a more basic, troubling question: could an outbreak of this scale happen again? A new report just published by the Boston Globe seems to indicate that not only co...
  • Massachusetts Looks to Clamp Down on Compounding in Wake of Scandal

    • 07 January 2013
    The governor of Massachusetts, Deval Patrick, has proposed new laws in a bid to strengthen the manner in which the state regulates the compounding of certain drug products. The development comes after hundreds of people were made ill and dozens more killed by pharmaceutical products compounded at a Framingham, MA-based company. That company, the New England Compounding Center (NECC), was found by regulators to have been manufacturing products contaminated with fungal men...
  • Massachusetts Loosens Ban on Industry Gifts

    • 10 July 2012
    The state of Massachusetts is loosening its controversial policy banning the pharmaceutical and medical device industries from giving physicians gifts, including compensated meals during continuing medical education. The measure has come under increasing fire in recent years as the economy has come to dominate matters of political discussion. Massachusetts' restaurant industry claimed the measure was hurting business as pharmaceutical companies no longer wined-and-dine...
  • Massachusetts Moves to Implement Quality System

    Massachusetts is working to implement a system that would change how the state reimburses hospitals and doctors, according to a report in The Boston Globe . The new system would reward providers that are able to lower their treatment costs while improving the quality of care provided to patients. "By examining the standards by which health care quality will be uniformly measured, we can do a much better job of understanding the value of care we are purchasing," wrote...