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  • Regulatory NewsRegulatory News

    Challenges Surrounding the Development and Manufacturing of ATMPs Continue

    The experience of conducting clinical trials with advanced therapy medicinal products (ATMPs) in a real-world clinical setting, according to a new European Medicines Agency (EMA) summary of a conference discussion, can mean “battling multiple and often ridiculous barriers.” The summary of a December regulatory conference in London on ATMPs notes that after a decade of having Regulation (EC) No 1394/2007 in force to speed access to ATMPs, “real progress has been m...
  • Restricted Travel, Conference Budgets Could Harm Regulators, Say Critics

    Government oversight bodies wary of fraudulent and unscrupulous expenditures made during agency-sponsored conferences have recently begun to crack down on how much money the agencies can spend, potentially to the detriment of legitimate exchanges of scientific information, say critics. After reports were raised about the General Services Administration (GSA) spending huge sums on an extravagant Las Vegas conference featuring a clown, mind-reader and $7,000 in sushi rol...
  • Bill Curtailing FDA Conference Spending Passes House

    A piece of legislation that could potentially curtail the US Food and Drug Administration's (FDA) ability to hold conferences has passed the US House of Representatives, reports The Hill . The legislation, the Government Spending Accountability Act (GSA Act) , comes on the heels of a scandal in which members of the Government Services Administration (GSA) held a conference that was held up by some congressmen as being a prominent example of governmental waste a...
  • Bill Would Introduce Greater Transparency, Spending Restrictions on FDA Conferences

    The US Food and Drug Administration (FDA) could find itself less able to put on jointly sponsored conferences if a new piece of legislation proposed in the US Senate is enacted into law. The bill, S. 3481: The Stop Wasteful Federal Bonuses and Conferences Act of 2012 , is the latest in a series of pushbacks against perceptions-real or imagined-that some government agencies spend too much money on lavish, taxpayer-funded conferences that provide little or no return o...