RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • Regulatory NewsRegulatory News

    EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record

    In 2015, the European Medicines Agency (EMA) maintained its momentum from 2014 , granting 93 positive opinions, 39 of which were for new active substances. The agency also recommended 18 orphan drugs for approval, breaking last year's record of 17. Notably, EMA trailed just behind the US Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) for the year. In 2015, CDER approved 45 new drugs, 21 of which had been granted orphan drug designati...
  • Regulatory NewsRegulatory News

    Researchers See Compounding, Imports as Fix for Pricey Off-Patent Drugs

    Three Johns Hopkins researchers are calling on the US Food and Drug Administration (FDA) to take action on expensive off-patent drugs by permitting bulk compounding and importation of generic formulations of the drug that are approved in other countries. Typically, when a drug goes off-patent and generic versions become available, the price of the drug goes down significantly. Sometimes, due to limited demand or low returns, the market for a particular generic becomes un...
  • Regulatory NewsRegulatory News

    FDA Seeks Participants for Emerging Pharma Manufacturing Tech Program

    The US Food and Drug Administration (FDA) is looking for companies to participate in a program that will review the latest in cutting-edge pharmaceutical manufacturing technology. For companies submitting an investigational new drug application (IND), original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) to the Center for Drug Evaluation and Research (CDER) with the use of such emerging manufac...
  • Regulatory NewsRegulatory News

    FDA Unveils New Office of Dietary Supplement Programs

    As part efforts to elevate the regulation of dietary supplements, the US Food and Drug Administration announced on Monday the creation of the new Office of Dietary Supplement Programs (ODSP). The new office, which previously worked as a division under the Office of Nutrition Labeling and Dietary Supplements, comes as the supplement industry has more than quadrupled in the 20 years since the establishment of that first division – from about $6 billion to more than $35 bil...
  • Regulatory NewsRegulatory News

    US Government Agencies Crack Down on Dietary Supplement Manufacturers

    In partnership with the Department of Justice, Federal Trade Commission and others, the US Food and Drug Administration (FDA), announced that after a yearlong sweep of dietary supplement makers, the agencies have filed civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced, an 11-count indictment unsealed Tuesday against Dallas-bas...
  • Regulatory NewsRegulatory News

    FDA Inaction Pushes McCaskill to Target Picamilon Retailers Directly

    Sen. Claire McCaskill (D-MO) is calling on ten major retailers to pull all supplements containing the ingredient picamilon after what she says has been “weeks of inaction” by the US Food and Drug Administration (FDA). The letters sent Monday to Amazon, the Vitamin Shoppe, CVS, Wal-Mart, Google, Vitamin World, Walgreens, Target, eBay and General Nutrition Corporation (GNC) call on them to pull from their shelves any dietary supplements containing picamilon as FDA has decl...
  • Regulatory NewsRegulatory News

    Senate Committee Advances Bill Redefining When a Drug is Officially Approved

    A bill that would effectively provide manufacturers with more certainty on the marketing exclusivity of approved drugs needing DEA clearance advanced unanimously through a Senate committee Wednesday. Background In order for a drug to be marketed, it must not only be approved by the US Food and Drug Administration (FDA), but the US Drug Enforcement Agency (DEA) must also schedule the drug to a particular class under the Controlled Substances Act (CSA). Under current law...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Prepares to Invest in State Drug Regulators (22 September 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Sets Terms for State Regulatory Investment Plan The Indian Ministry of Health has set the terms under which it will distribute the Rs 850 crore ($129 million) state regulatory investment package. States signing up to the memorandum of understanding (MoU) will only continue to receive funding if they achieve certain predefined goals. Ministry of Health officials ha...
  • Regulatory NewsRegulatory News

    Japan Edges out FDA for Fastest Approvals

    In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs). New Drug Approvals in ICH Countries A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014 , examines NAS approvals in the US, EU and Japan. The report finds that FD...
  • Regulatory NewsRegulatory News

    Attorneys General Call on FDA to Strengthen Supplement Safeguards

    • 03 June 2015
    The attorneys general of New York and Indiana are urging the US Food and Drug Administration (FDA) to "overhaul" the way in which it regulates the manufacture of dietary supplements. Background In the US, dietary supplements are defined as an oral product containing a "dietary ingredient," including vitamins, minerals, herbs, botanical ingredients, amino acids or other dietary substance. Despite commonly being used to support consumer health, dietary supplements are re...
  • RAPS' LatestRAPS' Latest

    RAPS Mid-Atlantic Career Day Draws Nearly 100 to Learn, Network

    Earlier this month, nearly 100 regulatory professionals, career changers, students and others gathered at the Montgomery County (MD) campus of Johns Hopkins University to learn, network and perhaps take the next steps in their regulatory careers. This was the second year for this regional career event. It was organized by RAPS DC/Baltimore Chapter Co-Chairs Nancy Singer (pictured), RAC, FRAPS, JD, president, Compliance Alliance LLC; and Daniela Drago, PhD, assis...
  • Regulatory NewsRegulatory News

    FDA Releases Guidance for Clinical Trial Sponsor-Investigators

    New guidance issued by the US Food and Drug Administration (FDA) instructs clinical trial sponsor-investigators on how to complete an investigational new drug application (IND)—an application used by FDA to approve the start of a new trial. As FDA notes at the outset of the new draft guidance document, Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators , "Sponsor-investigators seeking to do clinical research often do not have the reg...