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 Gearing up to Publish Clinical Data Ahead of New Clinical Trials Regulation

    The European Medicines Agency (EMA) is moving forward with its plan to release the clinical data used in marketing authorization applications. Background: Clinical Trials Regulation In April 2014, the European Parliament overwhelmingly passed a new regulation governing clinical trials, Regulation (EU) No 536/2015 , repealing Directive 2001/20/EC following a transition period lasting through 28 May 2016. One of the major changes in the new Clinical Trials Re...
  • RAPS' LatestRAPS' Latest

    Experts to Offer Ad, Promo and Labeling Advice at RAPS Virtual Event

    Advertising and promotion of healthcare products in the US are strictly regulated by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). As the Internet and social media have become increasingly powerful forces in our everyday lives and important sources of information on personal healthcare decisions, regulators, marketers and healthcare companies all have had to contend with a slew of new challenges. On Wednesday, 3 June, RAPS...
  • Regulatory NewsRegulatory News

    FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs

    • 22 May 2015
    The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week. The announcement, contained in the latest edition of the US Unified Agenda , contains 33 proposed and final rules FDA says it hopes to publish by the end of calendar year 2015. In practice, however, some rules have remained on FDA's Unified Agenda for years. FDA's latest update of the Unified contains two additional regulations compared to its las...
  • Regulatory NewsRegulatory News

    To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

    A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species. The data is intended to help advance FDA's efforts to promote the "judicious use" of antibiotics as part of a broader initiative to stem the rise of antimicrobial resistance (AMR). Under the 2008 Animal Drug User Fee...
  • Regulatory NewsRegulatory News

    FDA's Electronic Drug Labeling Proposal Comes Under Fire

    The US Food and Drug Administration (FDA) is coming under fire from patient safety groups and US legislators who say the agency's attempt to require certain drug labeling information to be distributed electronically instead of on paper "package inserts" could put patients at risk. Background In December 2014, FDA released a long-anticipated proposed regulation, Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Prod...
  • Regulatory NewsRegulatory News

    FDA Cracks Down on Facebook Marketing With Four New Letters to Companies

    The US Food and Drug Administration (FDA) is increasingly paying attention to social media, and in particular Facebook, as companies use the social networking platform to market their products. Six Warning Letters in Six Months In at least six Warning Letters issued since October 2014, FDA has referenced promotional claims used to market products on Facebook. Warning Letter Issued to: Reason for Letter Date Issued Vitalab Co., Inc. Unapproved Claims 16 Octo...
  • Regulatory NewsRegulatory News

    FDA Calls for Changes to Drug Advertising in Hopes of Increasing Patient Understanding

    The pharmaceutical advertising you see in magazines and newspapers will soon include less information in the hopes of better conveying what the actual risk of the drug is, the US Food and Drug Administration (FDA) announced today. Background The change represents a substantial shift in policy for the agency, which has traditionally favored the inclusion of as much risk information as possible in its advertising. For example, FDA's Office of Prescription Drug Promotion (...
  • Regulatory NewsRegulatory News

    High Failure Rate for AEDs Prompts FDA Change in Regulatory Policy

    • 02 February 2015
    The US Food and Drug Administration's (FDA) has finalized a change in policy that will soon require all Automated External Defibrillators (AEDs) to undergo a more rigorous regulatory review process meant to ensure the devices—which have failed in tens of thousands of reported cases since 2005—function reliably when they are needed most. Background The move, which was first announced in 2013 , relates to the way in which FDA approves medical devices. Currently, most hig...
  • Regulatory NewsRegulatory News

    FDA Drug Advertising Study Tracker

    The US Food and Drug Administration (FDA) frequently studies consumer behavior, particularly as it relates to how members of the public (and medical professionals) understand pharmaceutical advertising. Our FDA Drug Advertising Study Tracker keeps tabs on these studies and explains what they're trying to accomplish in plain terms.   Date Topic Study Summary January 2012 Corrective Advertising Study to assess whether and how corrective advertising—used to cor...
  • Regulatory NewsRegulatory News

    FDA Proposal Calls for Drug Labeling to be Distributed to Doctors Electronically

    In a long-anticipated and major move, the US Food and Drug Administration (FDA) has proposed a new rule requiring biopharmaceutical companies to distribute product labeling information to healthcare providers electronically. Background The proposed rule , Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products , comes after years of development at FDA. Under Section 1140 of the 2012 Food and Drug Administratio...
  • Regulatory NewsRegulatory News

    Cosmetic Companies, Watch Out: FDA Cracking Down on Improper Claims

    In recent years, a handful of cosmetic manufacturers have come under the harsh scrutiny of the US Food and Drug Administration (FDA) over claims their products could do far more than just change the skin’s aesthetics. Now the agency is again going after a marketer of cosmetic products, saying the company’s creams and moisturizers are more like drugs than beauty products. Background Cosmetic products are lightly regulated by US federal regulators. Unlike drugs, which mus...
  • Regulatory NewsRegulatory News

    This Week in Medical Device Regulation (17-21 November 2014)

    Welcome to This Week in Medical Device Regulation, your weekly review of regulatory news and intelligence. Regulatory Focus FDA Decides to Delay UDI Labeling Rule for Some Orthopedic Implants ( Regulatory Focus ) Pacemakers Get Hacked On TV, But Could It Happen In Real Life? ( Regulatory Focus ) Legislators Call on FDA to Study use of Plastic Microbeads in Toothpastes ( Regulatory Focus ) New Electronic Formatting Requirements in Canada for Class III and IV MDL Appl...