• Feature ArticlesFeature Articles

    Agency Meetings with the US Food and Drug Administration

    Informational guidance meetings with representatives from the US Food and Drug Administration (FDA) have been part of the original Prescription Drug User Fee Act ( PDUFA ) and were included in the PDUFA reauthorization in 2012. 1 A second revision of the FDA guidance document for these meetings was released as a draft for comments in March 2015. This new draft guidance updates the meeting instructions and incorporates changes resulting from the Food and Drug Adminis...
  • Regulatory NewsRegulatory News

    Meeting With FDA? Here's What Regulators do (and Don't) Want from Drug Companies

    A new guidance document issued by the US Food and Drug Administration (FDA) is meant to outline the agency's expectations for meetings that take place between FDA and a sponsor before and after the submission of a new chemical or biological drug product. Background Since the passage of the original Prescription Drug User Fee Act (PDUFA) in 1992, the pharmaceutical and biopharmaceutical industries have helped to fund the operations of FDA through payments of so-called ...
  • Regulatory NewsRegulatory News

    FDA Says it Will Regulate Robotic Exoskeletons

    The US Food and Drug Administration (FDA) has confirmed it will regulate all powered exoskeletons—a type of device intended to help paralyzed patients regain the ability to walk—as moderate-risk devices subject to a minimal level of premarket review. Background FDA's announcement comes as little surprise to close industry watchers. In December 2014, FDA notified exoskeleton manufacturer Ekso Bionics that its "Ekso" bionic suit would be subject to premarket controls. As...
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    DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases

    US drug regulators have set new production quotas for dozens of controlled substances regulated under the Controlled Substances Act (CSA) , establishing the quantities of the drugs which may be produced in 2015. Quota Adjustments In a 5 September 2014 Federal Register notice , the US Drug Enforcement Administration (DEA), which is charged with setting the quotas, released a list of dozens of schedule I and II controlled substances which will be subject to produc...
  • Regulatory NewsRegulatory News

    DEA, Following FDA Recommendation, to Toughen Regulation on Popular Class of Painkillers

    In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law. The move follows an October 2013 recommendation by the US Food and Drug Administration (FDA), which also recommended that the drugs be regulated as Schedule II products under the Controlled Substances Act (CSA), a 1970 law which places controls on substances known to be dangerous, prone to ...
  • Regulatory NewsRegulatory News

    Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns

    Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month. Background Pharmaceutical companies occasionally need to recall—that is to say, remove—products from the market. While the reasons for product recalls vary, they are commonly related to packaging defects, ...
  • Regulatory NewsRegulatory News

    Regulators Extend Comment Period on Proposed Overhaul of Device Reclassification System

    The US Food and Drug Administration (FDA) is extending by several months the comment period on a proposed rule which would make it easier for the agency to classify and reclassify medical devices in accordance with their perceived risk. Background The proposed regulation is required under a 2012 law known as the  Food and Drug Administration Safety and Innovation Act (FDASIA) .  Section 608 of the law  called for FDA to be given the authority to make classificati...
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    FDA Classifies Cellulite-Reducing Device as Class II

    The US Food and Drug Administration (FDA) has announced that it will soon classify surgical instruments intended to improve "the appearance of cellulite" as Class II medical devices, making it easier for them to be brought to market. Background In the US, medical devices are regulated by FDA's Center for Devices and Radiological Health (CDRH) and subject to three general classifications: Class I (for low-risk devices) Class II (moderate-risk devices) Class III...
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    FDA Moves Three Device Types into Class II Special Controls

    The US Food and Drug Administration (FDA) has proposed classifying three types of medical device products into its Class II regulatory controls scheme, subjecting them to special controls meant to ensure their efficacy, safety and quality. Background In the US, medical devices are regulated by FDA's Center for Devices and Radiological Health (CDRH) and subject to three general classifications: Class I (for low-risk devices), Class II (moderate risk) and Class III (high ...
  • Regulatory NewsRegulatory News

    FDA Proposes Strengthening Requirements for Rapid Flu Tests

    US Food and Drug Administration (FDA) regulators are proposing to reclassify some Influenza Antigen Detection Test Systems into a higher-risk category than the systems now inhabit, citing potential for the devices to fail to detect newer versions of the virus. Background The devices, which are used to detect the presence of influenza in a clinical sample, were Classified as low-risk Class I medical devices in 1982. Class I devices only require the company to adhere to g...
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    FDA Down-Classifies Colon, Intravascular Devices

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has proposed that two medical devices marketed prior to the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act) be subject to less stringent regulation. In two separate Federal Register announcements, FDA said it would permit intravascular administration sets and colon capsule imaging systems, respectively, to be classified as Class II devi...
  • FDA Cracks Down on Transvaginal Mesh, Will Require Companies to Submit Data or Pull Products

    The US Food and Drug Administration (FDA) has announced that it will seek to regulate transvaginal mesh products more stringently, calling them high-risk devices that will be required to undergo FDA's thorough premarket approval (PMA) process. Background Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pelvic organ prolapse (POP). In the EU, they have been used since the...