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  • Regulatory NewsRegulatory News

    Former Regulatory Affairs Director Charged With Insider Trading

    The US Securities and Exchange Commission (SEC) on Thursday charged Robert Gadimian, former senior director of regulatory affairs for Puma Biotechnology, with making more than $1.1 million thanks to non-public information linked to the company’s breast cancer treatment. The SEC alleges that Gadimian pocketed the illicit profits by secretly purchasing Puma stock and short-term call options based on non-public information he learned about positive developments in two cl...
  • 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    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has released a new draft guidance document meant to clarify when companies need to conduct an Environmental Assessment (EA) for gene therapy and other recombinant products.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...
  • BIO, Following PhRMA and EFPIA, Releases Clinical Trial Data Transparency Plan

    The Biotechnology Industry Organization (BIO) has announced that its member companies will soon grant wider access to clinical data, mirroring recent and similar efforts made by the pharmaceutical industry but falling short of calls made by transparency campaigners. Background In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, largely after some companies were found to have hidden unfavorable data regardi...
  • EU’s Scientific Committees to Look at Synthetic Biology

    The European Commission's three Scientific Committees have been requested to provide a joint scientific opinion on the relationship of Synthetic Biology (SB) to genetic modification of organisms, its implications for human and animal health and the environment, and the major gaps in knowledge necessary for performing a reliable risk assessment. Synthetic Biology is the term used to describe the creation of biological systems that do not exist in nature using engineeri...
  • Feature ArticlesFeature Articles

    Stem Cell-based Therapies and FDA Regulations

    Stem cell-based therapies are arriving in the clinic as Phase 1 studies. Which technological challenges and US Food and Drug Administration (FDA) regulations govern the development and translation of stem cell therapies into medical treatments? Irving Weissman, MD, PhD, discussed the current and future caveats of bringing stem cell therapies to clinical trials at the Institute of Stem Cell Biology and Regenerative (ISSCR) conference in San Francisco on 15 June 2010. "W...
  • EMA Releases New Draft Guideline on Ensuring the Quality of Animal-based Biotechnology

    The European Medicines Agency (EMA) released a new draft guideline for sponsors obtaining biologically active substances from transgenic animals on 31 May, saying new guidance was necessary to help manufacturers achieve quality measures when using the biotechnology. EMA explained the proposed guidance adheres to many of the same specific aspects of quality guidance already in place for other recombinant production systems. "As is the case with other biotechnologically ...
  • Report: India Moving to Regulate Biotechnology Research

    The Indian government is preparing to establish a new regulatory agency in charge of regulating biotechnology product research, transport, import, manufacture and use, reports The Economic Times . The new authority, tentatively known as the Biotechnology Regulatory Authority of India (BRAI), would be established under a new draft bill before the Indian parliament. The agency, in addition to its other duties, would also be in charge of formulating a risk assessment a...
  • New Biologic Sterility Regulation Issued by FDA

    The US Food and Drug Administration (FDA) is announcing its amendment of existing sterility test requirements for biological products, which it said will provide greater flexibility for manufacturers and encourage the use of cutting-edge technologies to assure the safety of biological products. In its 2 May Federal Register posting entitled Amendments to Sterility Test Requirements for Biological Products , FDA said its rule is "intended to promote improvement and i...
  • BIO Head Calls for New Position to be Formed at FDA to Boost Innovation

    The head of the Biotechnology Industry Organization (BIO), the leading trade group for biotechnology and biopharmaceutical organizations in the US, called on the US Food and Drug Administration (FDA) to make room in its organizational structure for a Chief Innovation Office (CIO), reports The Boston Business Journal . Speaking at the organization's annual meeting in Boston, BIO President and CEO James Greenwood said FDA has a duty to go beyond its mission to protect con...
  • Feature ArticlesFeature Articles

    Demystifying CMC Regulatory Strategy for Biologics - Part 4: Challenges of Adventitious Agent Control

    Note: Demystifying, according to Merriam-Webster's dictionary, is "to remove the mystery or mystique; to make rational or comprehensive." This is the fourth part of a series on demystifying CMC regulatory strategy for biologics. Part 1 covered the complexity of biologic CMC regulation; 1 Part 2 examined the major differences between biologics and chemical drugs; 2 Part 3 demonstrated that an effective CMC regulatory strategy was possible; 3 and Part 5 will address...
  • Group of Organizations Call for More Regulation of Synthetic Biology

    • 14 March 2012
    A group of more than 100 organizations are calling for new regulations on synthetic biology, saying current practices are inadequate to safeguard against safety issues, reports Science Magazine . The group-the Synthetic Biology Project (SBP)-is composed of a variety of environmental, watchdog and public interest organizations. The group put forth a series of recommendations recently that call for a moratorium on synthetic biology until adequate safety regulations can be...