Tighter Route: FDA Will Require Randomized Controlled Trials (RCTs) for CAR T-Cell Therapy Approval
The US Food and Drug Administration’s (FDA) Center for Biologic Research and Evaluation (CBER) has announced a significant shift in its regulatory approach for the approval of Chimeric Antigen Receptor (CAR) T-Cell therapies. Top agency officials indicate that, generally, the use of Randomized Controlled Trials (RCTs) will now be required to support new approvals in cancer treatment. This decision marks a transition from single-group studies (based only on response rate) to comparative trials with survival or time-to-event endpoints. The new stance aims to ensure that the benefits of these innovative therapies are measured with the highest standard of scientific evidence.
Clarity and Truth in Advertising: FDA Finalizes Guidance on Promotional Labeling for Biologics and Biosimilars
The US Food and Drug Administration (FDA) has finalized important guidance on the promotional labeling and advertising of reference listed drugs (RLDs), biosimilar products, and, crucially, interchangeable biosimilar products. The primary goal of this document is to ensure that all promotional communications about these products are accurate, truthful, and non-misleading. The publication fulfills a legal requirement (Biosimilar User Fee Amendments of 2022 – BsUFA III) and aims to address industry questions, establishing clear standards for presenting scientific data and information about interchangeability, a key concept for the adoption and success of the biosimilars market.
Navigating the Frontier: The Global Regulatory Landscape for AI/ML-Enabled Medical Devices
The incorporation of Artificial Intelligence and Machine Learning (AI/ML) into medical devices has the potential to revolutionize diagnosis, treatment, and health management. However, the adaptive and constantly evolving nature of these algorithms challenges traditional regulatory frameworks. This article provides an overview of the complex and dynamic global regulatory landscape—with a focus on leading agencies like the FDA (USA) and the European Union (EU)—highlighting the main challenges and the innovative approaches being developed to ensure the safety and effectiveness of these “learning” devices.
Global Techno vigilance: What changes with Anvisa’s adoption of IMDRF terminology
The Implementation of standardized IMDRF (International Medical Device Regulators Forum) codes for adverse event reporting.
Required Action: Update Standard Operating Procedures (SOPs) and Quality Management Systems (QMS).
Towards Sanitary Sovereignty: The Infliximab API and the Challenge of National Production
The recent authorization by Anvisa (Brazil’s Health Regulatory Agency) for the national production of the Active Pharmaceutical Ingredient (API) of infliximab by Bionovis marks a strategic step for the health and national security of Brazil. The biopharmaceutical, essential for treating autoimmune diseases, symbolizes the effort to reverse the critical dependence on imported inputs, which currently accounts for about 95% of the total. This article explores the historical importance of this recovery, the structural and professional capacity challenges involved, and the crucial role of policies such as the Productive Development Partnerships (PDPs) for the rebirth of the Health Economic-Industrial Complex (CEIS).
Navigating Regulatory Processes a Governmnet Reopens
Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.
Customs Revolution: ANVISA’s Phased Adherence to the New Import Process
This Blog addresses the intensified inspection efforts by the Brazilian Health Regulatory Agency (ANVISA) against the marketing of products without proper sanitary authorization. We analyze recent seizure cases involving Unregistered Hair Cosmetics (Botox and Straightening products) and Irregular Medicines/Herbal Supplements, highlighting how the absence of registration, notification, or proper listing exposes consumers to serious health risks and the industry to severe penalties.
The Shadow of Irregularity: Unregistered Medicines and Hair Cosmetics and the Hidden Risks
This Blog addresses the intensified inspection efforts by the Brazilian Health Regulatory Agency (ANVISA) against the marketing of products without proper sanitary authorization. We analyze recent seizure cases involving Unregistered Hair Cosmetics (Botox and Straightening products) and Irregular Medicines/Herbal Supplements, highlighting how the absence of registration, notification, or proper listing exposes consumers to serious health risks and the industry to severe penalties.
The Pharmaceutical Industry Calls for Expansion of the FDA’s PreCheck Program
Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.
Global Convergence and Predictability: ANVISA Resets the Game for Medical Devices and the 2024-2025 Regulatory Agenda
ANVISA implements a new regulatory framework for Medical Devices (RDC 848/2024), seeking international alignment, and publishes the 2024-2025 Regulatory Agenda, signaling regulatory priorities for sectors like cosmetics and medicines. Understand the impact of regulatory predictability in Brazil.
ANVISA on High Alert: The Use of Injectable Cosmetics and the Strict Enforcement of Good Manufacturing Practices in Brazil
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
Webinar Presents Preliminary Draft of the ICH Q3E Guideline on Impurities in Drug Products
The ICH Q3E Guideline (Impurities: Assessment and Control of Drug Substance and Drug Products) is a crucial directive aimed at harmonizing regulatory approaches for impurity control. This blog post details the main points of the preliminary draft presented in a recent webinar, discussing its impact and the need for preparation by companies, especially within the Brazilian regulatory context.