RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Feature ArticlesFeature Articles

    Dietary supplement class actions: Recent overlap with traditional FDA enforcement

    This article provides an overview of class action lawsuits targeting the dietary supplement industry. Recent trends indicate that companies should look beyond regulatory compliance and consider how a “reasonable consumer” would interpret claims in labeling, even claims that comply with FDA requirements. There are also important steps companies can take to prevent these lawsuits, as well as defenses that courts seem increasingly willing to accept. By staying aware of the cl...
  • Regulatory NewsRegulatory News

    Another Class I Recall of Ethicon Surgical Staplers, FDA Says

    Following seven serious injuries and one reported death, the US Food and Drug Administration (FDA) announced a Class I recall, the most serious type of recall, of some of Ethicon’s Flex Endopath surgical staplers because they may contain an out of specification component within the jaw of the device that could lead to malformed staples. Ethicon, a subsidiary of Johnson & Johnson (J&J), said that earlier this month it sent a letter to customers who purchased the affected...
  • Regulatory NewsRegulatory News

    FDA Proposes Additional Class II Devices to be Exempt From 510(k) Requirements

    Thanks to the 21st Century Cures Act , the US Food and Drug Administration (FDA) on Thursday proposed to exempt additional class II medical devices under five different product codes from 510(k) requirements. The proposed exemptions follow the finalization of a list in July 2017 of 1,003 types of class II devices that the agency also said do not present risks that require premarket notification. But for four of the five product codes proposed on Thursday, FDA has ...
  • Regulatory NewsRegulatory News

    Lawmakers Seek Clarity From FDA on Recall of Lifesaving Drug

    Following Takeda Pharmaceuticals’ recall of its hypoparathyroidism drug Natpara (parathyroid hormone) early last month, people who need the drug to stay alive are struggling to find it and ending up in the hospital. Vermont Democrat Senators Bernie Sanders, Patrick Leahy and Rep. Peter Welch sent a letter to the US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless on Friday seeking more information on how long the recall might last, what short- and lo...
  • Regulatory NewsRegulatory News

    Edwards Recalls Part of Transcatheter Heart System After One Death

    Last month, Edwards Lifesciences recalled its SAPIEN 3 Ultra Delivery System after reports of burst balloons during implantation, resulting in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, the US Food and Drug Administration (FDA) said Thursday. FDA said 17 injuries and one death were reported at the time when Edwards initiated the Field Corrective Action early last month. “The use of affected product may caus...
  • Regulatory NewsRegulatory News

    What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains

    The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should be exempted or granted a waiver. As far as what submission types warrant an exemption from eCTD requirements, FDA points to Type III drug master files (DMFs), which provide information on packaging or packaging materials in support of drug, generic drug or biologic applicat...
  • Regulatory NewsRegulatory News

    Edwards Lifesciences Recalls Devices After 3 Deaths Reported

    The US Food and Drug Administration (FDA) recently announced a Class I recall of more than 700 Edwards Lifesciences’ IntraClude Intra-Aortic Occlusion Devices after receiving 22 complaints related to balloon rupture or puncture, including three deaths. The device is used in patients undergoing cardiopulmonary bypass — a technique described by FDA as when “a machine temporarily takes over the function of the heart and lungs during surgery. When the IntraClude balloon is ...
  • Regulatory NewsRegulatory News

    New Impurity Found in Blood Pressure Drug Prompts Expanded FDA Recall

    The US Food and Drug Administration (FDA) on Friday announced that Indian drugmaker Hetero Labs is recalling 87 lots of losartan tablets distributed by Camber Pharmaceuticals after testing found the drugs contained a potentially carcinogenic impurity, N-Nitroso-N-methyl-4 aminobutyric acid (NMBA).   The recall is the latest in a series of recalls tied to the discovery of nitrosamine impurities in angiotensin II receptor blocker (ARB) drugs in the last year.   Previ...
  • Regulatory NewsRegulatory News

    PMA Denials: Why so Few?

    In the pharmaceutical industry, complete response letters, or rejections, are a common occurrence. And though they aren’t frequently explained in detail publicly, the public is still usually notified that the company has received such a letter. But in the world of medical devices, failing to win approval for a high-risk device is a much more closely held secret, and companies can withdraw their applications rather than be denied approval.   A Federal Register notice ...
  • Regulatory NewsRegulatory News

    Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating

    Medtronic and Monteris Medical are suggesting procedural techniques to reduce unintended thermal damage linked to their magnetic resonance-guided laser interstitial thermal therapy devices, the US Food and Drug Administration (FDA) said Thursday.   The agency summarized the new information from both medical device manufacturers and provided updated recommendations in two letters to health care providers. Medtronic issued three advisory letters between June and August t...
  • Regulatory NewsRegulatory News

    Alcon’s CyPass Market Withdrawal Escalates to FDA Class I Recall

    A US Food and Drug Administration (FDA) safety communication was escalated to a Class I recall for Alcon’s CyPass micro-stent systems over risk of eye damage in implanted patients.   FDA’s safety communication was issued last month based on a preliminary review of five-year post-surgery data from the COMPASS-XT study conducted by Alcon, the eye care division of Novartis. A second FDA safety alert involving the CyPass device was issued Wednesday in conjunction w...
  • Regulatory NewsRegulatory News

    FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices

    The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years. A Federal Register notice on guidance released Friday, which FDA said takes effect immediately, said: "FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Ag...