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    GOP Tax Reform Bill Would Repeal Orphan Drug Research Credits

    Republicans on Thursday rolled out their new tax reform bill, which among other provisions to lower taxes for Americans and businesses, proposes to repeal a provision that might cause the biopharma industry some concern. Under the House bill’s Subtitle E, section 3401 would repeal what amounts to half of the qualified clinical research costs for designated orphan drug products. Background Under the  Orphan Drug Act  of 1983, Congress sought to incentivize the d...
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    European Commission Consults on Recalibrating Aspects of Drug Patents, SPCs

    The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption. Background In the EU, SPCs, which apply to innovative pharmaceutical and plant protection products and have been increasingly used sinc...
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    FDA Halts Monkey Study on Nicotine Dosing

    FDA last month halted monkey research on nicotine dosing following concerns, including those raised in a letter from primatologist Jane Goodall. Although an FDA spokesperson told Focus that the decision to halt the study last month was made independently from Goodall’s letter to FDA Commissioner Scott Gottlieb, according to the letter , FDA was performing research at its National Center for Toxicological Research (NCTR) in Jefferson, Arkansas involving more than...
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    PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion

    The pharmaceutical industry lobbying group is harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health. "FDA has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further pro...
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    Report Highlights Cracks in the Market for Generic Competition

    As the US Food and Drug Administration (FDA) looks for ways to boost generic competition, a new working paper published by the National Bureau of Economic Research (NBER) suggests that competition among generic drugmakers slows over time, potentially leading to higher prices for older treatments and drug shortages. The analysis, authored by Ernst Berndt and Stephen Murphy of the Massachusetts Institute of Technology, and Rena Conti from the University of Chicago, reveals...
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    FDA, NCI to Collaborate Further on Cancer Research

    The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment. "The purpose of this MOU is to engage in scientific and programmatic collaborations in clinical proteogenomics cancer research, such as statistical experimental design, instrument/technolo...
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    EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research

    The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating that, when alternatives do not exist, the appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for pharmaceutical safety assessments. The opinion is part of a process to reevaluate the same conclusion from 2009 that “recognised that animals s...
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    FDA, DHS Find Cybersecurity Vulnerabilities in St. Jude Heart Devices

    The US Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) issued an advisory on Monday warning of cybersecurity vulnerabilities found in St. Jude Medical's Merlin@home wireless transmitter that could affect the company's line of implantable cardiac devices (ICDs). The Merlin@home device is used to communicate with a range of St. Jude's ICDs, including its radio frequency-ena...
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    Electronic Informed Consent: Final Q&A Spells Out New Recommendations

    The Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) on Wednesday finalized a question and answer (Q&A) guidance on using electronic systems to obtain informed consent for both HHS-regulated human research and FDA-regulated clinical investigations of medical products. The guidance focuses on procedures to be followed when using electronic informed consent (eIC) to help: Ensure prote...
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    FDA Unveils IRB Draft Guidance on Written Procedures

    The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow. IRBs are used to approve and oversee human research in order to ensure that participants are adequately protected. Under federal regulations, IRBs are required to maintain and follow written procedures...
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    EC Seeks to Update Scientific Opinions on Non-Human Primate Research, Safety of Breast Implants

    The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on Friday announced that it’s seeking more information to update its scientific opinions on the need for non-human primate research, production and testing of drugs and devices, and whether to update its opinion on the safety of PIP breast implants and the possible link between breast implants and a rare cancer. The review of using primates for biomedical research comes as...
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    Swedish Regulators Find Capsugel’s Oregon Site Not GMP Compliant

    Sweden’s Medical Products Agency (MPA) declared Monday that Capsugel subsidiary Bend Research’s Oregon manufacturing site does not comply with Europe’s good manufacturing practice (GMP) requirements. The statement of non-compliance follows a 24 February inspection of the site, which uncovered non-compliant operations with regard to non-sterile products, packaging and quality control testing. The inspection also found two critical, seven major and 12 other deficiencies ...