FDA Approves First Interchangeable Biosimilar to Perjeta (pertuzumab) Genentech
On November 13, 2025, the FDA approved Poherdy (pertuzumab-dpzb, by Shanghai Henlius Biologics Co., Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, by Genentech Inc.). U.S. Food and Drug Administration This marks the first biosimilar approved for Perjeta. U.S. Food and Drug Administration Indications for Poherdy include: The approval rests on comprehensive data comparing product […]
Essential Guide: Registering as a Medicinal-Product Broker in Ireland
Brief and Easy Explanation The document is the Health Products Regulatory Authority (HPRA)’s Guide to Registration Requirements for Brokers of Medicinal Products in Ireland. It spells out what companies or individuals must do if they act as a broker (i.e., arrange sales or purchases) of medicinal products (for human use) in Ireland under the Directive […]
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
In March 2022, the U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products.” This document provides detailed recommendations for industry and academic sponsors involved in the development of CAR T cell therapies, aiming to streamline the development process and ensure the […]
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of pharmaceutical products. One of its key responsibilities is monitoring post-market safety through pharmacoepidemiologic studies. The FDA’s guidance document, “Conducting and Reporting Pharmacoepidemiologic Safety Studies,” provides detailed recommendations on the design, conduct, and reporting of such studies. Overview […]
ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. One of its key regulatory requirements is the Medical Device Reporting (MDR) system, which mandates manufacturers to report adverse events and device malfunctions. The FDA’s guidance document, “Medical Device Reporting for Manufacturers,” provides clarity on […]
Electronic Submission Template for Medical Device De Novo Requests
The U.S. Food and Drug Administration (FDA) has released guidance on the importance of diversity in clinical trials to ensure that study populations reflect the demographics of the intended treatment population. The document, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” provides recommendations for sponsors to develop […]
Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
The U.S. Food and Drug Administration (FDA) has issued guidance to enhance the transparency and consistency of benefit-risk assessments in the regulatory review process for new drug applications (NDAs) and biologics license applications (BLAs). The document, “Benefit-Risk Assessment for New Drug and Biologic Applications,” outlines how the FDA evaluates the therapeutic benefits and associated risks […]
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
The U.S. Food and Drug Administration (FDA) provides detailed guidance on the nonclinical studies required to support Investigational New Drug (IND) applications. The document, “Nonclinical Safety Evaluation of Drug or Biologic Combinations,” outlines key recommendations for conducting preclinical studies that ensure the safety of investigational products before they proceed to human trials. This article highlights […]
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide
The U.S. Food and Drug Administration (FDA) continues to modernize regulatory processes by encouraging electronic submissions for Investigational New Drug (IND) applications. The FDA’s guidance document, “Electronic Submissions for IND Applications,” provides essential recommendations on transitioning from paper-based to electronic submissions, ensuring compliance with regulatory standards and improving efficiency. This article highlights key takeaways from […]