The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

  • RF Quarterly

    RF Quarterly, October 2021: Quality and compliance

    Welcome to the fall issue of RF Quarterly in which international experts from the US, EU, and Saudi Arabia examine quality and compliance and their governing regulations, with specific focus on data integrity, quality system design and management, current good manufacturing practice (cGMP), and postmarketing activities in relation to medical devices, pharmaceuticals, and biologics.   Pragmatism, integrity, and QMS Data reliability in all formats and parts of an o...
  • RF Quarterly

    PMS and the role of CAPA in the medical device regulatory cycle: A Saudi perspective

    It is important for both medical device manufacturers and regulators to establish robust postmarketing surveillance (PMS) of devices to ensure their continued safe use. The PMS system should include reactive and proactive components, that is, vigilance and safety signals assessments. Applying corrective and preventive actions (CAPAs) as a part of the quality management system improves the quality and safety aspects of the manufactured medical devices. This article examines...
  • Regulatory NewsRegulatory News

    FDA unveils data modernization plan

    A three-pronged plan to modernize the US Food and Drug Administration’s (FDA) approach to data was unveiled Wednesday, building on the agency’s previous technology modernization effort.   In a blog post announcing the new Data Modernization Action Plan (DMAP), Acting FDA Commissioner Janet Woodcock and Principal Deputy Commissioner Amy Abernethy write that data modernization is the “next step” for the agency after its 2019 Technology Modernization Action Plan (TMAP)...
  • 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

    FDA Warns 14 International Medical Device Companies

    The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines. By far the most common issues cited by FDA were: Number of Citations Issue 11 Failure to establish and maintain adequate procedures for imple...
  • Regulatory NewsRegulatory News

    FDA: Generic Opioids Must be 'No Less' Abuse-Deterrent Than Brand-Name Versions

    The US Food and Drug Administration (FDA) released a new draft guidance intended to ensure that generic versions of abuse-deterrent opioids meet the same standards for abuse deterrence as their brand-name counterparts for public comment on Thursday. The new draft guidance is part of a wider effort by FDA to address the national opioid epidemic, which claimed the lives of more than 28,000 Americans in 2014 . In February, the agency detailed its opioids action plan, sa...
  • Regulatory NewsRegulatory News

    Public Health Advocates Worry EMA and Industry are Too Cozy

    A coalition of health advocacy groups are worried that too much of the European Medicines Agency's (EMA) funding comes from private industry. Background Much like the US Food and Drug Administration (FDA), EMA receives much of its funding from fees it collects from industry for various services, such as application fees, scientific advice and pharmacovigilance fees. Generally, industry has been supportive of regulators charging fees for these services (although somet...
  • Regulatory NewsRegulatory News

    NIH Plots out Path Forward After Disastrous FDA Inspection

    • 22 June 2015
    The National Institutes of Health (NIH) says it is working quickly to figure out how to correct major deficiencies uncovered by the US Food and Drug Administration (FDA) last month at one of its drug compounding facilities. Background On 4 June 2015, NIH issued a statement saying it had "suspended operations" at its Pharmaceutical Development Section (PDS) following an inspection by FDA that found "a series of deficiencies." PDS is NIH's pharmaceutical development arm,...
  • Regulatory NewsRegulatory News

    How Should Regulators Warn Patients About New Drug Risks? UK Wants to Know

    In an effort to improve how safety issues are communicated, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a survey for healthcare professionals to provide input on how the communications are used. Background The survey is being launched as part of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action initiative, which was launched to "help medicines regulators operate pharmacovigilance systems...
  • New China FDA Document Clarifies Device Crackdown Plan

    On 15 March 2014, the China Food and Drug Administration (CFDA) issued a question and answer document designed to clarify the purpose of an earlier 13 March 2014 notice on the new national Special Action Program (SAP). That notice, sent to Chinese provinces and municipalities, called on local authorities to crack down on illegal activities relating to medical devices, and especially medical device registration, production, distribution and use.  The Program wi...
  • Supreme Court Prepares to Hear Amgen's Challenge to Securities Fraud Lawsuit

    • 12 June 2012
    The Supreme Court of the United States (SCOTUS) said it agreed to hear a challenge from life sciences manufacturer Amgen regarding a lawsuit alleging the company inflated its stock price by misleading investors about the safety of its anemia drugs, Aranesp and Epogen. Amgen is reportedly contesting the class-action nature of the lawsuit, which it says could have the perverse effect of placing severe financial pressures on companies if allowed to stand. "At issue," expla...
  • Pfizer Executives Sued Under Securities Laws for Allegedly Concealing Clinical Trials Results

    • 02 April 2012
    A federal judge refused to dismiss a case against Pfizer and five former executives for allegedly violating federal securities law by concealing clinical trial results, reports The Courthouse News Service . The class action lawsuit, filed by the Teacher's Retirement System of Louisiana, accuses the company and executives of violating federal securities laws by omitting the results of unfavorable clinical trials from public filing statements made by Pfizer. The defendan...