• Regulatory NewsRegulatory News

    US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval

    The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars. The case, pitting biologics manufacturer Amgen against Novartis subsidiary and biosimilar manufacturer Sandoz, attempted to clarify what’s known as the biosimilars "patent dance," which is the process by which companies must exchange and figure out the pa...
  • RAPS' LatestRAPS' Latest

    Knowledge Center Provides RAPS Members With Free Content

    • 13 June 2016
    RAPS members now have a new and powerful tool to help them stay informed. The Member Knowledge Center , a new members-only content portal, provides a catalog of carefully curated free RAPS resources in one convenient place. The Knowledge Center gives members exclusive access to RAPS’ educational resources. “We wanted to find a way to help our members engage with RAPS’ high-quality products,” said Lindsay Currie, RAPS’ director of stakeholder engagement. “We pla...
  • Poll: More Than Half of Americans Favor Increased Regulatory Authority for States

    • 21 May 2012
    A poll conducted by Rasmussen Reports finds a slim majority of Americans are in favor of increasing the authority given to states to overrule a decision made by the US Food and Drug Administration (FDA). Rasmussen's poll, released 19 May, surveyed 1,000 likely voters across the US and had a margin of error of +/- 3% (95% Confidence Interval). The survey found 52% of respondents in favor of the statement: "Suppose the Food and Drug Administration denies approval for...
  • Asian Harmonization Working Party Joins ISO, IMDRF

    The Asian Harmonization Working Party (AHWP) has announced it has been accepted as a member in both the International Medical Devices Regulators Forum (IMDRF) and the International Standards Organization (ISO). AHWP is a non-profit dedicated to the harmonization of medical device regulations, and includes among its members China, India, Saudi Arabia, Korea, South Africa and Pakistan. The organization said IMDRF had extended an invitation for AHWP to join its Forum as ...
  • Dalli: Commission Looking to Overhaul Clinical Trials Directive

    John Dalli, the European commissioner for health and consumer policy, spoke 7 March about the need to review and modernize the Clinical Trials Directive before a joint event put on by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Roche Group. "This debate comes at a very good time - the Commission will come forward with a proposal to revise the Clinical Trials Directive later this year," said Dalli. Dalli noted clinical trials hav...
  • New Bill Looks to Streamline Inspections

    A new bill introduced by Representative Brian Bilbray (R-CA) would rein in regulatory overlap by preventing states from "requiring duplicative inspections" of manufacturing plants. Bilbray's bill, the Science and Technology Regulatory Relief Act of 2012 (H.R. 4044) , prevents states from requiring US Food and Drug Administration-inspected manufacturers to undergo a state-sanctioned inspection. Exceptions are provided if the state receives complaints of unsafe produ...
  • EC's John Dalli Calls for Stricter Safety Controls, Postmarketing Surveillance for Medical Devices

    The European Commission's (EC) Commissioner for Health and Consumer Policy John Dalli called for the EC to "look at the sector of medical devices as a whole," saying that both the EC and national agencies need to review how medical devices are approved in the EU in a speech given to the press on 9 February . "As you know, we had already been working on a revision of the Medical Devices legislation and within the context of the ongoing preparatory work we had i...
  • Obama Administration, Plaintiffs File PPACA Briefs

    The US Department of Justice (DOJ) and a group of 26 states ("state petitioners") both filed briefs with the Supreme Court of the United States (SCOTUS) on Friday, 6 January outlining their respective arguments regarding the Patient Protection and Affordable Care Act's (PPACA) constitutionality and the severability of certain components of the law. The DOJ brief focuses on the question of whether or not "the minimum coverage provision is a valid exercise of Congress...