• FDA Says Focus on Regulatory Science Key to Advancing Personalized Medicine and Helping Patients

    A new report published by the US Food and Drug Administration (FDA) seeks to further advance its frequent narrative that good regulation is good for both business and the American public, this time focusing on how its efforts in the area have advanced personalized medicine. Background The term "regulatory science," which FDA defines as the "science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regula...
  • European Parliament Proposes Changes to Pharmacovigilance User Fee Collection System

    • 23 October 2013
    A new legislative draft report posted by the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) on 18 October 2013 calls for changes to be made to the way in which user fees are payable to the European Medicines Agency (EMA) for some application filings. EMA, like the US Food and Drug Administration (FDA), partially funds its review work through user fees payable to the agency for many routine activities, such as the registratio...
  • FDA Proposes Making Antibiotic Monitoring Report More Useful

    Nearly five years after the passage of the Animal Drug User Fee Amendments Act (ADUFA) of 2008, the US Food and Drug Administration (FDA) is proposing to expand upon its data reporting requirements, saying companies will need to include even more data on the antimicrobial drugs they sell for use in food-producing animals. Background The policy is being advanced through proposed rulemaking released on 26 September 2013 by the agency. It was first released as a propose...
  • FDA Gears up to Tackle Problem of Underrepresented Populations in Clinical Trials

    When the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in 2012, among its many provisions was one not noticed by many: Section 907. The section requires FDA,  within one year of the law's passage, to publish a report "addressing the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups-including sex, age, race and ethnicity-is included in [product] applications ...
  • Pharmaceutical Industry Experts Slam FDA's PDUFA Report, Calling it too Vague to be Useful

    The pharmaceutical and biopharmaceutical industries have long been supportive of the user fee schemes used to fund the US Food and Drug Administration (FDA). Originally passed under the Prescription Drug User Fee Act (PDUFA) in 1992 in response to the delay in approvals in drugs in the US compared to in the EU, the basic fee structure-with some added changes and conditions-has been reauthorized another four times, most recently with the passage of the Food and Drug Adm...
  • GAO Report Gives Credence to FDA's Pharmaceutical Compounding Claims

    A new report just published by the Government Accountability Office (GAO) confirms what US Food and Drug Administration (FDA) officials have long argued: They simply don't have sufficient authority to regulate compounding pharmacies with the same level of vigor as they do traditional pharmaceutical manufacturers. Background In the waning months of 2012, a massive outbreak of fungal meningitis was linked to supposedly sterile versions of methylprednisone acetate manufact...
  • European Parliament Committee Says Changes to Proposed Device Legislation Needed

    • 31 July 2013
    A new opinion report just published by the European Parliament's Committee on the Internal Market and Consumer Protection on the Committee on the Environment, Public Health and Food Safety's (ENVI) medical device and IVD proposals calls for changes to be made, citing the proposals' potential to be overly restrictive to the "free movement of products." Background In April 2013, ENVI made an unprecedented proposal to require many medical devices to undergo a premarket aut...
  • In Response to MDUFA Commitments, FDA Prepares to Make Changes to IDE Submission System

    Medical device regulators at the US Food and Drug Administration (FDA) are planning to unveil a new technology platform in August 2013 through which industry will be expected to submit clinical trial requests, the agency announced today. The change is occurring as a result of FDA's commitments to industry under the Medical Device User Fee Act of 2012, a subset of the Food and Drug Administration Safety and Innovation Act (FDASIA) . As outlined in a commitment letter a...
  • WHO Report: Regulators need to Collaborate, Evaluate and Innovate

    An extensive new report issued by the World Health Organization (WHO) calls on global regulatory bodies to refine and improve their respective systems for approving new medicines, balancing the needs of public health and innovation to "ensure a continuous flow of the new medicines most needed by society." The Report The report, Priority Medicines for Europe and the World Update Report, 2013 , is a follow-up to a 2004 report by the same name, and was prompted by the...
  • Government Report Finds Mixed Opinions on Proposed Drug Labeling Overhaul

    A new report published by the Government Accountability Office (GAO), an intra-governmental watchdog agency, has found that the US Food and Drug Administration's (FDA) efforts to substitute three types of paper- based prescription drug labeling with an electronic-based labeling system is being met with strongly mixed reactions, indicating that the effort may not work as intended. Background FDA currently regulates the content and layout of prescription drug labeling, in...
  • European Commission Releases First Report on the Pediatric Regulation

    The European Commission today published a progress report on medicines for children covering the five years since the Pediatric Regulation came into force. Although it will take several more years to fully assess the impact of the legislation due to long drug development cycles, this preliminary review points to significant improvements in the pediatric medicines landscape: better and safer research, more products for children on the EU market and more information for p...
  • Federal Agency Says FDA's Benefits Far Outweigh its Costs

    A new draft report out by the White House's Office of Management and Budget (OMB), the government's regulator of regulators, shows that the cost-benefit ratios of the US Food and Drug Administration (FDA) vastly outweigh its costs to industry and the public at large, potentially giving the regulator clout with legislators who are increasingly looking to make budget cuts. The Report The draft report was published in response to the Regulatory Right-to-Know Act of 2001,...