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  • Regulatory NewsRegulatory News

    Best of 2017: What Readers Clicked on This Year

    From Trump to biosimilars to a new digital health pilot run by the US Food and Drug Administration (FDA), here are the top 10 most-read articles of 2017, with some updates on what has occurred since the stories were published. 10. EMA to Suspend More Than 300 Drugs due to Unreliable CRO Studies Back in March, the European Medicines Agency (EMA) recommended the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies w...
  • Regulatory NewsRegulatory News

    FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics

    The age of precision medicine, with treatments targeted to specific patients based on a companion test identifying the need for such a treatment, is pushing the US Food and Drug Administration (FDA) to release new and more detailed draft guidance on how companies can co-develop a therapeutic alongside what the agency is calling an in vitro companion diagnostic device, or IVD companion diagnostic. The draft released Thursday, entitled "Principles for Codevelopment of an...
  • Regulatory NewsRegulatory News

    Second Generic Version of ADHD Drug Concerta Found to Have Problems

    US regulatory officials say they have identified not one but two supposed generic copies of the attention deficit hyperactive disorder (ADHD) treatment drug Concerta that have failed to demonstrate required levels of equivalency. Background On 13 November 2014, Irish generic drugmaker Mallinckrodt announced that FDA had determined that its generic version of Concerta (methylphenidate hydrochloride ER tablets) were not therapeutically equivalent to their reference drug...
  • Regulatory NewsRegulatory News

    FDA Says it Discovered Problems With Generic Version of ADHD Drug Concerta

    A generic attention deficit hyperactive disorder (ADHD) drug manufactured by Mallinckrodt has been found by the US Food and Drug Administration (FDA) to not be sufficiently equivalent to its reference drug, Concerta. Background Generic drugs are approved through FDA's abbreviated new drug application (ANDA) process. During that process, FDA is primarily concerned with data showing the generic drug is bioequivalent to the reference listed drug (RLD), sometimes referred t...
  • Facing Criticism, FDA Rethinking Some Therapeutic Equivalence Standards

    US regulators are taking a second look at the way generic drug applications for extended-release generic drug obtain approval several weeks after finding that Teva Pharmaceuticals and Impax Laboratories' Budeprion XL 300mg, supposedly generic to GlaxoSmithKlines' Wellbutrin 300mg, was in fact not therapeutically equivalent. The finding was a setback for the US Food and Drug Administration (FDA), which has fastidiously maintained that nearly all drugs approved through i...
  • Feature ArticlesFeature Articles

    Tarantulas: Possible Lifesavers?

    • 07 August 2012
    In the past, I have written about many creatures in the animal kingdom, and several of them were on the top of the most hated and feared list. Rats, spiders and snakes are prime examples. My earlier article about spiders described how spider webs could be used to fashion artificial ligaments or tendons. 1 Tarantulas, another arachnid in that species, may prove valuable in treating a number of pathologies. This article will describe them, their venom, mechanisms of acti...
  • Brazil: Meeting to Discuss New Criteria for Therapeutic Indications

    The Board of Anvisa, the national regulatory authority of Brazil, is scheduled to review new regulations governing the format of "non-print" instructions for use of health products and the criteria for a therapeutic indication at its next public meeting. The Board will also receive a report by the Chief Executive Officer of Anvisa, Dirceu Barbano, on the international meeting of national regulators held in Geneva on 18 May that was organized by the agency on the topic of...
  • Skerritt Takes Reins as New Head of TGA

    Australia's Therapeutic Goods Administration (TGA) announced on 1 June the confirmation of Dr. John Skerritt as the new National Manager of the agency, ending a month-long lead-up process. Skerritt replaces Dr. Rohan Hammett, who resigned from the agency in December 2011 , and comes to the agency in the midst of a tremendous reorganization to combine the regulatory authorities of Australia and New Zealand into a single trans-national regulatory authority known as the ...
  • TGA Announces New Head of Agency

    Australia's Therapeutic Goods Administration (TGA) announced it has appointed Dr. John Skerritt, previously the Deputy Secretary of the Department of Primary Industries in the Victorian government, as the new national manager of TGA. In a statement posted on the agency's website on 2 May, TGA said Skerritt will take control of the agency at the end of May 2012 and said Skerritt is highly qualified to run the agency well. "Skerritt currently leads more than 1200 staff (i...
  • WSJ: Sponsors Find New Clinical Trials Difficult for Old Drugs

    When pharmaceutical manufacturers take a second look at their drugs to look for additional therapeutic indications, it's often a win-win for manufacturers and patients alike. Manufacturers are given the opportunity to receive additional revenue and marketing exclusivity, while patients are given the chance to receive a drug with a well-established risk pedigree and efficacy for new-and possibly neglected-indications. At least that's the theory. Getting these products t...