• Feature ArticlesFeature Articles

    Subpart H and the implications for ad promo

    Advertising and promotion (ad promo) of prescription drugs is regulated by the US Food and Drug Administration (FDA). In 1992, the agency implemented Subpart H of Title 21 of the Code of Federal Regulations (CFR) to allow for the accelerated approval of new drugs for serious or life-threatening illnesses. Approval of a drug through the Subpart H pathway introduced a range of regulatory requirements, some of which had specific implications for the ad promo of Subpart H drug...
  • Regulatory NewsRegulatory News

    Omnibus spending bill expands FDA’s unannounced foreign inspections pilot

    The recently enacted omnibus spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to expand its unannounced foreign facility inspection pilot program in a quest to achieve parity with domestic inspections, which are mostly unannounced.   The FY 2023 spending bill was signed by President Biden on 27 December. The bill authorizes $3.5 billion in budget authority for FDA in FY 2023, a 6.5% increase compared to the previous ...
  • Feature ArticlesFeature Articles

    Enhancing diversity in clinical trial populations: An agency-industry perspective

    Achieving health equity – the opportunity for all patients to live a healthy life, irrespective of their circumstances – requires the collective effort of the entire medical product development ecosystem. An example of such a collaboration took place at the September 2022 RAPS Convergence in Phoenix, Arizona, with joint presentations by representatives from the US Food and Drug Administration (FDA), Health Canada, and industry (Pfizer) who discussed enhancing diversity in ...
  • Regulatory NewsRegulatory News

    FDA guidance proposes devices be deemed adulterated for refusing inspections

    The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market if companies refuse to allow inspections of their facilities without adequate justification. Under current FDA policy, only drugs can be deemed adulterated if FDA inspectors are barred at the door.   The draft align with an update in the law under the FDA Reauthorization Act (FDARA), which requires devices also be dee...
  • Regulatory NewsRegulatory News

    FDA describes plans to expand remote regulatory assessments

    The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as it eases out of pandemic response mode. The guidance covers triggers for when FDA will request or require remote assessments and how these audits will be coordinated with onsite inspections.   These tools are not intended to replace onsite inspections but inste...
  • Regulatory NewsRegulatory News

    ICMRA explores hybrid inspections, postapproval changes with new pilots

    A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.   The International Coalition of Medicines Regulatory Authorities (ICMRA) announced the pilots on 24 June. The group said that the pilots were prompted by its July workshop which “highlighted the need for more convergence on CMC [chemistry, manufac...
  • Regulatory NewsRegulatory News

    FDA official: Virtual audits, records requests may be sticking around

    CHICAGO – The US Food and Drug Administration (FDA) plans to use a hybrid inspection model going forward as it eases out of its pandemic response mode, combining a mix of record requests, remote interactive evaluations (RIEs) with onsite inspections if needed, asserted Alonza Cruse, director of FDA’s pharmaceutical quality operations.   Cruse discussed how the agency is transitioning to normal operators at the 22 June Drug Information Association (DIA) annual meeting ...
  • RF Quarterly

    The history of clinical trial disclosure

    The scope and complexity of requirements for global clinical trial disclosures and data sharing have increased substantially over the last 20 years. Most leading countries have specific regulations pertaining to trial conduct, and many have set up patient registries for collecting and analyzing data on patient outcomes. More recently, authorities have initiated inspections relating to disclosure to ensure compliance with regulations, and transparency advocates continue to ...
  • Regulatory NewsRegulatory News

    FDA caught up on domestic preapproval inspections, foreign inspections still a challenge

    The US Food and Drug Administration (FDA) eliminated its backlog of overdue domestic preapproval inspections, yet such progress has been stunted at the international level as getting to sites in China has remained a challenge amid the country’s COVID-19 pandemic restrictions. So asserted Patrizia Cavazzoni, the director of FDA’s Center for Drug Evaluation and Research (CDER), who provided an update on the center’s activities and priorities for 2022 at the Food and Drug ...
  • Regulatory NewsRegulatory News

    Clinical trial diversity: Sponsors seek clarity on data sources, timing

    Drugmakers and clinician organizations praised the US Food and Drug Administration’s (FDA) recent draft guidance containing recommendations on developing a Race and Ethnicity Diversity Plan to improve enrollment of underrepresented racial and ethnic groups in clinical trials. But in public comments, they also called for greater details on the types of data that should be used to assess adequate enrollment of these populations, how these diversity plans should be applied to...
  • Regulatory NewsRegulatory News

    Cavazzoni: Pandemic-era tools, learnings are here to stay

    The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going forward and has renewed calls for industry to embrace digital technologies and decentralized models for conducting clinical trials. The pandemic has also prompted the agency to re-evaluate its hiring practices, and to adopt the use of alternative tools in lieu of onsite inspections, which have become a permanent fixture in the agency...
  • Feature ArticlesFeature Articles

    FDA ‘high-risk’ foreign inspections: Post‒COVID-19 response to GMP challenges

    This article examines the US Food and Drug Administration’s (FDA) return to inspections that were put on hold during the ongoing COVID-19 pandemic. It outlines the agency’s oversight of drug and biological products during the pandemic and its plans moving forward. The authors summarize the agency’s guidance and policies, industry considerations, and recommendations to manufacturers preparing for their next FDA inspection.   Keywords FDA, inspections, quality, risk m...