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  • Regulatory NewsRegulatory News

    When to Submit a New 510(k): FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized two guidances detailing when a new 510(k) is required for changes made to medical devices or their software. In August 2016, FDA released the two draft guidances, five years after the agency's first attempt to replace its 1997 guidance on 510(k) changes. But the agency withdrew the 2011 draft guidance after Congress ordered it to rethink the policies discussed in that version, which industry complained woul...
  • Feature ArticlesFeature Articles

    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...
  • Regulatory NewsRegulatory News

    Capsule Supplier Changes: FDA Offers an Updated Policy

    Changing the supplier of gelatin capsules used to encase drugs constitutes a minor change, and does not require a prior approval supplement (PAS), according to a US Food and Drug Administration (FDA) policy that went into effect Monday. Prior Approval Supplement When a drugmaker makes changes to an already approved product, including changes to its specifications, manufacturing process or label, the company must notify FDA of the change. Depending on the seriousness of...
  • Feature ArticlesFeature Articles

    The New KYSS Principle: Know Your Supplier's Supplier

    • 27 May 2016
    • By
    This article introduces the KYSS principle to align a robust supplier management program with regulatory requirements and includes initial identification and qualification of suppliers, supplier quality agreements and both initial and ongoing supplier monitoring. Introduction Deaths, illnesses, injuries and many recalls have been attributed to fraudulent, counterfeit or adulterated components of finished pharmaceuticals and medical devices. 1 These tragic consequence...
  • Regulatory NewsRegulatory News

    Confusion Pushes FDA to Change Antidepressant’s Brand Name

    The US Food and Drug Administration (FDA) on Monday approved a brand name change for Takeda’s antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from confusion with AstraZeneca’s blood-thinning medicine Brilinta (ticagrelor). The new brand name of Brintellix will be Trintellix, and the tablets will look nearly identical and are expected to be available in June, FDA said. “No other changes will be made to the la...
  • Regulatory NewsRegulatory News

    FDA Clarifies how Generic Drug Companies can Change Their Manufacturing Processes

    A new guidance document issued by the US Food and Drug Administration's (FDA) drug and biologics review divisions explains how the agency handles Prior Approval Supplements (PAS) under its generic drug user fee amendments (GDUFA) program. Background A PAS is an application which seeks to make changes to an already-approved application , such as an Abbreviated New Drug Application (ANDA), which is used by FDA to approve generic drugs. Unlike other change notification ...
  • Regulatory NewsRegulatory News

    New Blood Clot Warnings Added to Labels of Testosterone Products

    The US Food and Drug Administration (FDA) yesterday said it will require manufacturers of testosterone products about an increased risk of venous blood clots, known as venous thromboembolism (VTE)—the latest warning for a class of drugs that has seen no shortage of scrutiny from regulators and researchers alike. Background Testosterone products, commonly used to treat low levels of testosterone in men, or "low-t," have long been associated with higher risks of so...
  • Regulatory NewsRegulatory News

    Second Major Sleep Drug Associated With Impaired Driving as FDA Dials Back Recommended Dosing

    The US Food and Drug Administration (FDA) has again issued a warning about a sleep drug, this time requiring a labeling change for the popular sleep drug Lunesta after data indicated that some patients experienced long-lasting effects that could impair their ability to function, even after a full night's sleep. Background Sleep drugs have long been on FDA's radar, primarily due to their association with impaired driving. The concern has been that some patients respond a...
  • Feature ArticlesFeature Articles

    Establishing Effective Device Supplier Qualifications

    Supplier qualification is an important quality system requirement that, when performed effectively, ensures with a high level of confidence that a purchased product will consistently meet specified requirements. An effective supplier qualification procedure should include risk analysis, quality auditing and the use of qualified analytical test methods and statistical techniques to determine supplier capability. A risk score assigned to suppliers, based on the result of s...
  • EU:European Commission Opens Review of Variations Guidance

    The European Commission has opened a public consultation on proposed changes to the current guidance on making changes to the terms of approved marketing authorizations, otherwise known as the "Variations Regulation." The document takes into account scientific and technical progress since the entry into force of guidelines in January 2010 and addresses an update required by the implementation of the new Pharmacovigilance legislation, which will enter into force in July...
  • UK Regulator: Don't Overreact to PIP Scandal

    The head of Britain's Medicines and Healthcare products Regulatory Agency (MHRA), Kent Woods, said modest improvements are necessary to correct deficiencies exposed during the Poly Implant Prothese scandal . In remarks made at a press conference on 16 February, Woods called for "better surveillance and reporting of any problems with medical devices on the market, and more coordination between national medical regulators," wrote Reuters . Woods added that while he t...