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.
Building Transparency: FDA Experts Offer Essential Tips for Assembling SBOMs in Medical Devices
The recent discussion among experts at the Medtech conference, highlighted by the FDA, underscores the critical importance of the Software Bill of Materials (SBOM) in medical device cybersecurity. Although SBOM generation tools are still in their early stages, the consensus is clear: manufacturers must start working immediately on assembling these documents. The SBOM is now an essential regulatory requirement for “cyber devices” and crucial for managing risks and ensuring patient safety. Experts emphasize the need for simplification, the inclusion of key partners in the process, and attention to the details of the human-readable format, which complements the machine-readable format required by the FDA.
RDC 954/2024: ANVISA’s New Milestone for Simplified Drug Registration in Brazil
RDC 954/2024 represents a significant advance in the simplification and optimization of the drug registration process with ANVISA. The regulation establishes clear criteria for simplified registration, aiming for greater efficiency and agility for the regulated sector. The blog post will detail the key points of the RDC and the importance of ANVISA’s guidance for the correct application of the new rules, highlighting how GRP Brazil can help companies adapt to this new scenario.
The New Digital Frontier of Health: Understanding SaMD (Software as Medical Device) Regulation by ANVISA
The advance of technology has turned applications, platforms, and Artificial Intelligence (AI) into essential tools for diagnosis and treatment. ANVISA (Brazil’s National Health Surveillance Agency) is updating its rules to keep pace with this evolution. The focus is on RDC 657/2022, which establishes the foundation for the regulation of Software as a Medical Device (SaMD), ensuring that these digital innovations are safe and effective for the patient. The recent expansion of the target audience for the Agency’s inspection course reinforces its commitment to training and oversight in this sector.
IMDRF Releases Key Guidance Documents for Medical Device Software
The International Medical Device Regulators Forum (IMDRF) has released two key guidance documents to support the regulation of medical device software. These include Good Machine Learning Practice for Medical Device Development: Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents aim to enhance global regulatory harmonization and assist medical device manufacturers in navigating compliance requirements for software-based and AI-driven technologies.
Health Canada Makes Clinical Information on Medical Devices Publicly Accessible
Health Canada Makes Clinical Information on Medical Devices Publicly in a significant move toward greater transparency in healthcare, Health Canada (HC), the country’s medical device regulator, has announced that clinical information submitted in support of medical device applications is now publicly available. This development marks a crucial step in empowering healthcare professionals, researchers, and the general public with access to critical data.
FDA Proposes Framework to Bolster Credibility of AI Models in Drug Development
The U.S. Food and Drug Administration (FDA) has unveiled a groundbreaking draft guidance aimed at advancing the credibility of artificial intelligence (AI) models in drug and biological product development. This marks a significant milestone as it is the agency’s first formal guidance on AI in this domain, underscoring its commitment to innovation while maintaining rigorous regulatory standards.
FDA Suggests Collecting data on Ovarian Toxicity in Cancer Drug Trials
The US Food and Drug Administration (FDA) is recommending that sponsors include the collection of data on ovarian toxicity in the development of cancer drugs.
FDA Proposes Removing Oral Phenylephrine as Active Ingredient in OTC Nasal Decongestants After Review
In November 2024 the Food and Drug Administration announced its proposal to remove phenylephrine from the approved list of over-the-counter drugs to treat nasal congestion, citing evidence that the oral version of the drug is ineffective.
Industry Pushback on : Biosimilar, Biological medicines Industry, Food and Drug Administration, Generic Drug
The U.S. Food and Drug Administration (FDA) recently proposed issuing biosimilar product-specific guidance to streamline the approval process for biosimilars. While this move aims to make the pathway for biosimilar approvals more predictable and accessible, it has faced pushback from the pharmaceutical industry. Many industry leaders argue that this approach could inadvertently hinder innovation, increase regulatory burdens, and complicate the pathway to biosimilar market entry.
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. The Generic Drug User Fee Amendments (GDUFA) provides a framework for improving the efficiency and transparency of the review process for generic drug applications, known as Abbreviated New Drug Applications (ANDAs). One key aspect of this framework is the review of Drug Master Files (DMFs), which are critical for ANDA submissions involving drug substances, intermediates, or excipients that are not fully described in the ANDA itself.
US FDA Publication on Integrating Artificial Intelligence into Healthcare Product Copy
On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.