• ReconRecon

    Recon: AstraZeneca seeks EUA for preventative COVID antibody; EMA considers rolling review for Merck's COVID drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer/BioNTech COVID-19 vaccine effectiveness drops after 6 months, study shows ( Reuters ) J&J files for authorization of COVID-19 vaccine booster ( Reuters ) AstraZeneca Submits Preventive Covid-19 Treatment for FDA Authorization ( WSJ ) ( Reuters ) Pharmacy chains failed to prevent opioid misuse, U.S. jury hears ( Reuters ) Henrietta Lacks' estate says ph...
  • 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

    Data integrity and compliance with GxP: A pragmatic approach

    Issues related to data integrity have been in the news in recent years, often focusing on companies receiving citations from regulatory agencies regarding unreliable computer data. While the laboratory and computer data were the primary focus, data reliability in all formats and in all parts of the operation are critical to ensure products are reliable. While many also think this issue applies only to quality and operations, if the information listed in the regulatory doss...
  • RF Quarterly

    Current good manufacturing practices and quality system design

    Quality by design, or the principle of building quality into a product and testing, was introduced in 2011 as process validation guidance. Today it is codified within the Title 21 section 820. The quality management system (QMS) encompasses this principle in all areas of healthcare manufacturing – including drugs, biologics, and devices – and, with compliance, can ensure the safety and effectiveness of all manufactured products. The establishment, implementation, and maint...
  • RF Quarterly

    Medical device quality management systems

    Introduction A quality management system (QMS) is one of the five medical device conformity assessment elements. 1 Manufacturers of medical devices are expected to implement, document, and maintain a QMS that “ensures the medical devices it designs, manufactures, and supplies to the market are safe, perform as intended, and comply with the relevant provisions of the regulations in the countries where the product is made available.” 2   Today, a QMS is seen as a ...
  • RF Quarterly

    Medical device compliance and postmarketing activities

    This article provides an overview of medical device postmarketing requirements. These requirements include, but are not limited to, establishment registration, medical device reporting, and device tracking. Additional requirements include postmarket surveillance studies required under Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 522 and postapproval studies required at the time of approval of certain application types.   Introduction: Establishment registra...
  • 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...
  • RF Quarterly

    Biologics compliance

    This article discusses the phases from the product development to commercialization. Biologics are subject to 21 Code of Federal Regulations in order to meet the criteria established for safety, purity, and potency. Compliance to these regulations should be built based on a quality management system and risk management to capture changes during the product development and process validation phases and prepare a product and facility for inspection readiness. Post commercial...
  • ReconRecon

    Recon: J&J will reportedly seek authorization for boosters this week; Pfizer loses suit over copay assistance programs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US McKinsey Never Told the FDA It Was Working for Opioid Makers While Also Working for the Agency ( ProPublica ) Gilead and Kite nab another approval for Tecartus, as leading CAR-T portfolio continues to grow ( Endpoints ) U.S. Supreme Court rejects challenge to New York tax on opioid companies ( Reuters ) Pharmacy chains face first trial over US opioid epidemic ...
  • Regulatory NewsRegulatory News

    FDA to convene VRBPAC on vaccines for younger children plus Moderna, J&J boosters

    Amid the nationwide rollout of booster shots of the Pfizer-BioNTech COVID-19 vaccine, the US Food and Drug Administration (FDA) on Friday announced it will convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss potential booster doses for the other two US-authorized COVID-19 vaccines developed by Moderna and Johnson & Johnson (J&J) later this month.   The committee will also meet on 26 October to discuss Pfizer's anticipated request...
  • Regulatory NewsRegulatory News

    FDA drafts safety reporting guidance for drug and device investigators

    The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting duties for investigational drugs and devices.   The draft , published on 29 September 2021, is focused exclusively on the role of investigators – not sponsors – and merges past final guidance from 2009 and 2012 on safety reporting that was previously mixed in with advice to sponsors. The prior guidance will remain in effect until the new ...
  • Regulatory NewsRegulatory News

    FDA draft guidance outlines criteria for conducting benefit/risk assessments

    The US Food and Drug Administration (FDA) issued a draft guidance on Wednesday that aims to shed light on how it assesses the benefits and risks of new drugs in deciding whether to approve them. The guidance also describes how companies can present benefit and risk information in their applications to increase chances of approval.   The guidance also addresses how sponsors can collect patient experience data to inform their benefit/risk assessments. It was developed ...