• Regulatory NewsRegulatory News

    French Biotech’s Manufacturing Operations Suspended by ANSM

    France’s National Agency for Medicines and Health Products Safety (ANSM) has suspended the manufacturing operations at French biotech company Theravectys’ Villejuif, France-based site for one year (beginning last September) following an inspection in November. ANSM said in a report released Monday that its inspection from 17 to 20 November 2015 of the Paris-based Pasteur Institute spinoff raised 45 deficiencies, including five critical and 17 major deficiencies. The comp...
  • Regulatory NewsRegulatory News

    EMA Committee Finds No Link Between HPV Vaccines and Rare Conditions

    After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used." PRAC Review There are currently three centrally-authorized HPV vaccines in the EU – Gardasil/Silgard, Gardasil 9 and Cervarix – to protect against cervical cancer and other HPV related conditions. Upon...
  • Feature ArticlesFeature Articles

    Ebola—Expedited Pathways for Drugs and Vaccines in Europe: The EMA Perspective

    This article discusses the European Medicines Agency (EMA) facilitated expedited pathways for drug and vaccine approval to enable fast access to market to fight emerging diseases, such as Ebola. To date, neither the US Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) has approved a vaccine or therapy for the treatment of the Ebola virus, which in Guinea, Liberia and Sierra Leone has had a case fatality rate as high as 71%. 1 Regulatory a...
  • Regulatory NewsRegulatory News

    India Fines GSK, Sanofi for Alleged Anti-Competitive Practices

    The Indian subsidiaries of two European drugmakers, GlaxoSmithKline (GSK) and Sanofi, have been fined for allegedly plotting to charge higher prices in a government tender for a meningitis vaccine, The Economic Times reports. Investigation and Allegations The Competition Commission of India (CCI) is tasked with enforcing The Competition Act , which "prohibits anti-competitive agreements, abuse of dominant position by enterprises," and oversees corporate mergers a...
  • Regulatory NewsRegulatory News

    US Government Immunizes Future Manufacturers of Ebola Vaccines from Legal Liability

    The US Department of Health and Human Services (DHHS) is providing a gift to manufacturers of prospective vaccines meant to protect patients against the Ebola virus: Protection from legal liability. In an announcement in the 9 December 2014 edition of the Federal Register , DHHS said it was issuing a new declaration that would "provide liability protection for activities related to Ebola virus disease vaccines consistent with the terms of the declaration." Protection f...
  • Regulatory NewsRegulatory News

    FDA, CDC Preparing Updated Form to Record Vaccination Problems

    The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form. Background In a notice published in the Federal Register on 24 November 2014, CDC said it's accepting public input on its proposed Vaccine Adverse Event Reporting System (VAERS) 2.0 form. VAERS is used by FDA and CDC, which co-administer th...
  • Regulatory NewsRegulatory News

    Canada Launches Ebola Vaccine Trial

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The Canadian Institutes of Health Research (CIHR) and the Public Health Agency of Canada (PHAC) have provided funding for a Phase I clinical trial using Canada’s Ebola vaccine (VSV-EBOV), Canada's Minister of Health, Rona Ambrose, announced last week.  The Canadian Im...
  • Regulatory NewsRegulatory News

    FDA, CDC Put $18M Behind Adverse Event System for Vaccines

    The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have awarded a new, $18 million contract meant to support its existing Vaccine Adverse Event Reporting System (VAERS) over the next five years. The award will go to Virginia-based SRA International, the company announced in a 17 November 2014 press release . SRA has supported FDA's VAERS program since 1999, it said. VAERS is used by FDA to collect and analyze reports of vacci...
  • Regulatory NewsRegulatory News

    With New Rule in Place, FDA Establishes Procedures for Submitting Vaccine Safety Problems

    A new draft guidance document issued this week by the US Food and Drug Administration (FDA) establishes best practices for the submission of safety reports related to the use of vaccines. Background FDA has since 2009 been advocating for a rule which would require all mandatory postmarketing safety reports to be submitted to the agency in electronic form (instead of paper), saying that the change could allow it to better process, review and archive the documents. The r...
  • Regulatory NewsRegulatory News

    FDA Chides GSK Subsidiary for Flu Vaccine Manufacturing Troubles

    A Canadian subsidiary of pharmaceutical company GlaxoSmithKline (GSK) has been accused by the US Food and Drug Administration (FDA) of deviating from good manufacturing practice (GMP) regulations while manufacturing the flu vaccine FluLaval . The allegations, contained in a Warning Letter released by FDA on 24 June 2014, stem from a 31 March-9 April 2014 inspection of ID Biomedical Corporation's—a GSK subsidiary since 2005—Quebec facility. The bulk of the allegati...
  • 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...
  • Regulatory NewsRegulatory News

    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...