• Feature ArticlesFeature Articles

    Perspectives on FDA Review of Medical Devices: Part I

    In recent months, I have attended various medical conferences and trade shows that have highlighted many of the most promising med-tech innovations. From genetically modified mosquitoes (to fight malaria), to robotic-based artificial limbs to a surgical cure for hypertension, it seems healthcare innovation is alive and well. Yet, as a regulatory professional, I was struck by the numerous calls for the US Food and Drug Administration (FDA) reform and the claims FDA is st...
  • EMA Report: Approval Numbers Likely to be Lower than 2011

    The European Medicines Agency (EMA) has released a mid-year report detailing its progress in 2012, showing a projected decline in the number of submitted applications even as products seeking orphan designations surged 30%. The report, highlighted in an EMA press release on 10 October, was originally reported to EMA's management board by Executive Director Guido Rasi. Rasi, who took over EMA this year after Thomas Lonngren stepped down in the midst of controversy, ha...
  • Is FDA on Pace to Beat Its 2011 Drug Approval Numbers?

    The US Food and Drug Administration (FDA) is potentially on pace to approve fewer new drug entities than it did in 2011, according to several sources. An analysis by The Street of the remaining 2012 FDA advisory committees-panels of experts who provide non-binding advice to the agency regarding whether to approve a new drug product-shows just 23 more drugs set to go before US regulators before the end of the year. The list includes Pfizer's anti-rheumatoid arthri...
  • UK Proposes Reimbursement-based Accelerated Approvals Process

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is calling for comments on a newly-released proposal that would see some patients receiving medicines faster under an approval pathway focused more on reimbursement than on the complete assessment of a product's safety and efficacy. The pathway, called the Early Access to Medicines Scheme, "would provide a scientific opinion on the benefits and risks of medicines" from MHRA, which would in turn form the ...
  • EMA Looks Back on a Tough Year as it Forges Ahead

    Kent Woods wants stakeholders to know he understands: 2011 was a tough year. As Chair of the European Medicines Agency's (EMA) Management Board and head of the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Woods has had a front seat to many of Europe's most difficult regulatory problems. The last year saw EMA's long-time Executive Director, Thomas Lönngren, resign in the midst of controversy and a new ED, Guido Rasi, inherit an agency in the midst...
  • FDA Anticipates Spike in Oncology Drugs, Reduction in Shortages

    Could 2012 be the year a long-running drought in product approvals and availability finally ends? The US Food and Drug Administration (FDA) is of the opinion that it might just be-if only for oncology products, at least. Reuters reports Dr. Richard Pazdur, FDA's head of the Office of Hematology Oncology Products within the Center for Drug Evaluation and Research (CDER), told attendees of the American Society of Clinical Oncology (ASCO) conference in Chicago he anticipa...
  • Report: FDA Taking Longer to Approve Drugs With 'Unmet Medical Needs'

    A new report published jointly by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) is claiming the US Food and Drug Administration (FDA) is taking longer to approve pharmaceutical products for some areas of unmet medical need as the result of unclear regulatory standards. The report, " Managing Priorities: Therapeutic Area Variation in FDA Drug Regulation ," is a follow-up to one co-authored by CHI and BCG in 2011. The 2011 report notes FDA...
  • Former FDA Commissioner Says Lack of Resources to Blame for Lack of Innovative Approvals

    The former Commissioner of the US Food and Drug Administration (FDA), Andrew von Eschenbach, said in a Wall Street Journal op-ed he believes a shortage of resources at FDA is behind a proliferation of regulatory uncertainty and a lack of innovative approvals. "[Breakthrough technologies] have been stalled by regulatory uncertainty, because the FDA doesn't have the scientific tools and resources to review complex innovations more expeditiously and pioneer regulatory pat...
  • FDA Drug Approvals Up 42% in 2011, Regulatory Quality Highlighted

    The US Food and Drug Administration (FDA) approved 30 new molecular entities (NMEs) during 2011, marking a 7-year high for the agency, according to an analysis by Bloomberg . Notable success stories include Johnson & Johnson and GlaxoSmithkline, both of which tripled their approvals from the year prior.  The entire industry, however, may stand to benefit from the 42% increase in approvals as patent expiries begin in earnest this year. Twenty-one patented me...