• Regulatory NewsRegulatory News

    FDA Wants Sponsors of Biotech Products to Assess Product's Impact on Environment

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has released a new draft guidance document meant to clarify when companies need to conduct an Environmental Assessment (EA) for gene therapy and other recombinant products. Background Under 21 CFR 25 of the Code of Federal Regulations , most pharmaceutical and biotechnology companies are required to submit EAs as part of their approval package. The assessments are gene...
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    Medical Device Data Systems to be Exempt from Regulation, FDA Says

    In a stark reversal, US Food and Drug Administration (FDA) regulators today said they would exempt medical device data systems (MDDS)—systems used to collect and store data from other medical devices like weight scales and glucose meters—from regulation, abandoning an earlier plan to regulate them as Class I ("low-risk") medical devices. The announcement comes more than three years after FDA down-classified MDDS devices from Class III ("high-risk") to Class I. Whil...
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    FDA Releases New Animal Rule Guidance With Focus on Vaccines and Animal Health

    The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens. Background In 2002, Congress authorized and FDA passed the Animal Efficacy Rule ("Animal Rule"), a regulation which permits the approval of some products based on safety testing...
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    FDA Launching Pilot Program to Assess Vaccine Safety Reporting Capabilities

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is launching a pilot program intended to assess its capacity to receive reports of adverse events related to the use of vaccines. At present, CBER—working in tandem with the Centers for Disease Control and Prevention (CDC)—receives vaccine-related adverse events electronically through its Vaccine Adverse Event Reporting System (VAERS), which accepts the International Conferenc...
  • BIO Argues Changes Needed to FDA's Drug Shortage Rule to Account for Vaccines

    Should vaccines be considered under the US Food and Drug Administration's (FDA) recent drug shortages rule? No, argues the Biotechnology Industry Organization (BIO), which explained in a recent letter to FDA that the Centers for Disease Control and Prevention (CDC) has been able to adequately handle shortages of vaccines on its own for at least the last decade. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injectable drug...
  • China Clarifies GMP Compliance Deadline for Vaccines, Injectables

    According to a bulletin issued by the China Food and Drug Administration (CFDA) on 31 December 2013, manufacturers of blood products, vaccines and injectable drugs that have not obtained certification of compliance with the revised (2010) good manufacturing practices (GMP) may not market those products as of 1 January 1 2014.  Companies with facilities that have passed GMP inspection prior to January 1, 2014, may continue to manufacture products, but those produc...
  • EU Regulators Launch Vaccine-Focused Pharmacovigilance Project

    EU pharmacovigilance is expanding in a big way for vaccine products, the European Medicines Agency (EMA) has announced. Under a new plan unveiled on 26 November 2013, EMA will be working with other regulatory bodies on a new five-year project known as the Accelerated Development of Vaccine Benefit-Risk Collaboration in Europe ( ADVANCE ), the intent of which is to better assess the risks and benefits of a vaccine throughout its lifecycle. Unlike many drugs, vaccines are...
  • HRSA Closes Loophole for Quadrivalent Vaccines

    Regulators at the Health Resources and Services Administration (HRSA) have finally closed a loophole in the National Vaccine Injury Compensation Program that had left legislators scrambling to pass a fix over the summer. Background To incentivize research and development in vaccine products, the US government has set up a special fund, known as the National Vaccine Injury Compensation Program (NVICP), as well as a specific vaccine claims court system. The two are intend...
  • Obama Signs Law Closing Vaccine Loophole

    • 26 June 2013
    US President Barack Obama has signed into law legislation intended to close a loophole that would have prevented a new vaccine manufactured by French manufacturer Sanofi from obtaining the same legal liability protections - and patients the access to injury compensation - as traditional vaccines. Background The problem doesn't have to do with the safety of Sanofi's quadrivalent vaccine, known as Fluzone. By all accounts the vaccine is extremely safe, and regulators have...
  • Legislators Move to Close Loophole Affecting Sanofi's New Influenza Vaccine

    When the US Food and Drug Administration (FDA) approved a new four-strain flu vaccine manufactured by French life sciences manufacturer Sanofi in early June 2013, it didn't just mark a momentous occasion for regulatory officials within Sanofi - it also exposed a potential loophole in how US officials accommodate the safety of vaccine products, one legislators are now eager to fix. Background The problem uncovered doesn't have to do with the safety of Sanofi's quadrivale...
  • Cuba-Brazil Bilateral Agreement Fosters Drug and Vaccine Development

    According to the director of Brazil's national regulatory agency (Anvisa), Dirceu Barbano, the cooperative exchanges of regulatory information and technology facilitated by a bilateral agreement between Cuba and Brazil have been "beneficial" in the development of new drugs and vaccines. The two countries have established a cooperative framework through which they have produces millions of meningococcal vaccines intended for use in Africa. According to reports, the agreem...
  • EMA Releases Draft Guideline on Hepatitis B Vaccines

    The European Medicines Agency (EMA) has released a new guideline to instruct sponsors of clinical trials on best practices for assessing antibody-based products used to prevent the hepatitis B virus. The 2 December 2012 draft guideline, On the Clinical Investigation of Hepatitis B Immunoglobulins , is specifically aimed at vaccines, which EMA explains are an effective method for protecting uninfected, healthy individuals against infection by the hepatitis B virus. T...