Welcome to the March issue of RF Quarterly, which examines patient-focused regulatory practice and includes articles on patient-reported outcomes in regulatory decision making; real-world evidence and postmarket surveillance data; generating evidence for racial and ethnic minorities in oncologic drug development; structured, patient-focused benefit-risk assessment; and the role of the high-performance integrated virtual environment in research using patient-generated data....

Ophthalmic products are regulated under quality standards published in the Code of Federal Regulations (CFR), United States Pharmacopeia (USP), and various US Food and Drug Administration (FDA) guidance. Application of these standards has recently been affected by the legal requirement for the FDA to standardize the regulatory approach to ophthalmic products whose components are considered devices. The agency communicated the update through a guidance outlining the phase-i...

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...

Co-promotion agreements between two pharmaceutical companies amplify marketing efforts for a product and boost market penetration. It entails collaboration between the companies during the review and approval of the promotional and nonpromotional product information materials. This article will focus on co-promotion in the regulatory advertising and promotion (ad promo) setting. It includes basic principles and best practices in implementing the promotional review process ...

This article discusses a three-step approach to providing regular and ongoing advertising and promotion (ad promo) training to maximize efficiencies and elevate the review experience for cross-functional team members. The authors provide considerations for optimizing training and provide resources for use at each stage of the process.   Keywords – ad promo training resources, MLR training, PRC training   Introduction Pharmaceutical companies strive to stre...

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 ...

This article provides a brief overview of what to expect when starting out as a regulatory advertising and promotion (ad promo) reviewer and includes recommendations for some basic introductory resources.   Keywords – advertising and promotion, regulations, reviewing, starting out   Introduction Regulatory ad promo review is more an art than a science, and learning how to apply the specific laws, regulations, and guidances is an ongoing process. There is a lot...

The social science research team at the US Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) engages in extensive research into prescription drug materials for direct-to-consumer purposes and aimed at healthcare providers. Much research has been completed, and much is ongoing. This article provides a summary of the research that was published in 2022.   Background The FDA social science research team fulfills an important role at...

It is important to consider current FDA guidance and past enforcement actions as digital media becomes a larger space for pharmaceutical promotion aimed at healthcare providers and consumers. Strategizing for and developing  promotional materials for digital platforms should be thoughtful and deliberate given the limited scope of guidance available from the FDA. This article presents an overview of the available FDA guidance and enforcement actions for digital promotion an...

Social media platforms have enabled prescription drug and biologic industry sponsors (market application holders) to engage more actively with a broader range of consumers and healthcare professionals and have become an integral part of an effective marketing campaign strategy. This article discusses compliance violations cited for social media direct-to-consumer advertisements (DTCAs) as listed in warning and notice of violation (NoV) letters issued by the US Food and Dru...

There is no specific definition in the People’s Republic of China regulatory framework clarifying the term “digital health,” but there is general acceptance that the term refers to digital technologies applied across the healthcare sector. 1,2 This article describes recent updates to the regulatory framework for digital health applications that qualify as medical devices under China’s regulations.   Keywords – China, digital health, regulatory   Introduction...

India’s Central Drugs Standard Control Organization (CDSCO) implemented the New Drugs and Clinical Trials Rules in 2019 to expedite the drug development and approval processes. This article provides an overview of those processes; explains the rule-specific terminology, such as the definitions of “drug” and “new drug” under Indian law; and outlines strategies for speeding up the approval processes and optimizing registration of prescription medicines in India.   Keywo...