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  • Regulatory NewsRegulatory News

    US Government Wants to Know More About the Biotech Ecosystem

    The White House’s Office of Science Technology and Policy (OSTP) on Tuesday sought input from any and all biotech stakeholders on the innovation, products, technology and data derived from biologically-related processes and science that drive economic growth, promote health and increase public benefit. Referred to as the “Bioeconomy,” OSTP said it’s seeking comments before 23 October from the public, including those with capital investments, those performing research or...
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    CA Congressman Seeks More FDA Outreach for Biotech Start-Ups

    Rep. Eric Swalwell (D-CA) on Friday sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf seeking further assistance for start-up biotechnology companies in the Bay Area. Swalwell said several companies have expressed their concerns on “the complexity and length of the regulatory process” that many do not have the resources to navigate. He also said the companies are seeking a local San Francisco Bay Area FDA office to provide face-to-fac...
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    FDA Continues Crackdown on Chinese Drug Manufacturers With new Warning for Xiamen

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Chinese drug manufacturer Xiamen Origin Biotech over "significant deviations" in the company's manufacturing practices for active pharmaceutical ingredients (APIs). As imports of pharmaceuticals from China and India have increased, so has FDA's enforcement of manufacturing for companies exporting to the US. In 2015, FDA carried out 132 inspections of Chinese manufacturers, more than twi...
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    FDA Warns German Contract Manufacturer Over API Stability Concerns

    The US Food and Drug Administration (FDA) has warned Baesweiler, Germany-based contract manufacturer BBT Biotech GMBH over deviations from good manufacturing practices (GMPs), including the failure to provide stability data to support expiration dates for active pharmaceutical ingredients (APIs). The warning letter, sent 16 May and released Tuesday, follows an inspection at the API manufacturing facility in May 2015 during which FDA inspectors found BBT Biotech did not p...
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    Biotech Company Settles With SEC Over Failure to Disclose FDA Concerns

    The Securities and Exchange Commission (SEC) on Tuesday settled fraud charges against Massachusetts-based biotech company AVEO Pharmaceuticals for $4 million after three former executives allegedly concealed the US Food and Drug Administration’s (FDA) level of concern about approving the cancer drug tivozanib in public statements. SEC had alleged that AVEO concealed FDA’s concerns with tivozanib in statements to investors by omitting the critical fact that FDA staff had ...
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    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...
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    UK Agencies Look to Overhaul Cancer Drugs Fund

    The National Health Service (NHS) of England and the National Institute for Health and Care Excellence (NICE) on Thursday introduced a new proposal to transform the £340 million ($520 million) Cancer Drugs Fund (CDF) to allow patients to have earlier access to new treatments while real-world evidence is still being collected. As many in the UK, like the US, are distraught over the rise of cancer drug prices, NICE and NHS are proposing to turn the CDF, beginning in April ...
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    Using Twitter as a Regulatory Intelligence Tool: 460 Accounts Worth Following

    Finding information about the latest regulatory news can be profoundly difficult. Even with thousands of websites, hundreds of newsletters and dozens of subscription services, information that could affect you and your company can still slip through the cracks. Luckily, there's help, and lots of it—but only if you know where to look. Regulatory Intelligence on … Twitter? One of the most under-utilized sources of regulatory information is Twitter , a social media platf...
  • 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...
  • 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...