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  • Regulatory NewsRegulatory News

    BIO, PhRMA and Others Urge Further FDA Clarity on Drug Compounding

    The Biotechnology Innovation Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), Pew Charitable Trusts and other groups earlier this week sent letters to the House and Senate urging further support for FDA oversight of drug compounders and enforcement of the 2013 Drug Quality and Security Act .  "If FDA is not permitted to maintain that line between traditional compounding and outsourcing facilities, patients are put at risk, sta...
  • Regulatory NewsRegulatory News

    Senate Committee Takes First Step on Rising Pharmaceutical Prices

    The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down. Sen. Lamar Alexander (R-TN) opened the hearing by highlighting the extent to which biopharmaceutical companies pay for the development of new medicines, and to note there will be two more hearings focused on R&D and supply chain expenses, ...
  • Regulatory NewsRegulatory News

    BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics

    The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics. While both organizations say the revised draft guidance is a step in the right direction, BIO says several aspects of the guidance still raise concerns. Background FDA first issued its draft guidance on mixing, diluting or repackaging biological...
  • Regulatory NewsRegulatory News

    Pew: Insurance Claims Must Include UDIs to Track Device Safety

    The Pew Charitable Trusts says that adding unique device identifiers (UDIs) to insurance claims forms is critical to the success of several federal initiatives to improve medical device safety and patient care. Dr. Josh Rising, director of healthcare programs at Pew, told Focus on Wednesday about his organization's efforts to improve device surveillance and how incorporating UDIs into claims forms can aid those efforts. "The goal of Pew's medical device project is to ...
  • Regulatory NewsRegulatory News

    Industry Weighs Integration of UDIs Into Medical Device Registry Network

    The Advanced Medical Technology Association (AdvaMed) is at odds with a government task force over how unique device identifiers (UDI) could be used in a proposal for a coordinated registry network for medical devices. Background In 2012, the US Food and Drug Administration (FDA) issued a report, Strengthening Our National System for Medical Device Postmarket Surveillance , which detailed the agency's vision for improving device surveillance. One of the report's...
  • Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA

    [Editor's note: an earlier draft of this article incorrectly claimed the hearing was on 28 March. The hearing is being held on 29 March, 2012] A Senate hearing is scheduled to hear testimony Thursday(29 March) on the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) , marking the first hearing on either piece of legislation in the Senate. Directors Janet Woodcock of the US Food and Drug Administration's (FDA) Center for Drug Evaluat...
  • Poll: Americans Widely in Favor of Prescription Drug Regulation

    A poll published 23 February by the Pew Research Center for People and the Press found that the US public is broadly in favor of regulations of prescription drug products . Thirty-nine percent of the 730 respondents thought that regulations on prescription drugs should be strengthened, 33% wanted to see them maintained at current levels and 20% wanted to see regulations reduced. The numbers were little-changed from 1995, when 37% wanted regulations strengthened, 30% wa...