Regulatory Blog

The guidance Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle  was issued on 30 March 2026 , updating and superseding the earlier 2016 guidance, and providing comprehensive recommendations on how patient preferences can inform benefit-risk assessments. The FDA recognizes that patients living with diseases or conditions develop first-hand insights into treatment benefits and risks. Their perspectives can play a critical role in evaluatin

The U.S. Food and Drug Administration (FDA) has issued updated guidance in 2026 to help drug manufacturers effectively respond to FDA Form 483 observations issued at the conclusion of CGMP inspections. This guidance focuses on improving communication, investigation quality, and corrective actions, ensuring that manufacturers address compliance gaps while protecting patient safety and product quality. Scope and Purpose This guidance applies to both domestic and international d

Introduction This guidance, "General Considerations for the Use of New Approach Methodologies in Drug Development" , published as a draft in March 2026 , provides a framework for using New Approach Methodologies (NAMs)  in drug development. NAMs include approaches such as: In vitro models (simple and complex systems) In chemico methods In silico modelling The goal of this guidance is to improve human-relevant toxicology prediction  and reduce reliance on animal testing. Backg

Introduction This guidance, "Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs ", published in March 2026 , provides detailed recommendations for applicants submitting Abbreviated New Drug Applications (ANDAs)  for topical drug products. It focuses on physicochemical and structural (Q3) characterization, which plays a critical role in demonstrating product performance and bioequivalence (BE). Topical products, especially semisoli

Medical devices intended for weight management play an important role in addressing obesity and related health conditions. The U.S. Food and Drug Administration (FDA) has issued guidance to help manufacturers understand regulatory expectations when developing and submitting premarket applications for medical devices with indications associated with weight loss. The FDA guidance titled “ Medical Devices with Indications Associated with Weight Loss: Premarket Considerations ”  

The development of biosimilar and interchangeable biological products is an important part of improving access to biological medicines. To support this process, the U.S. Food and Drug Administration (FDA) has issued guidance documents that clarify regulatory expectations under the Biologics Price Competition and Innovation Act (BPCI Act) . Two key FDA guidance documents provide detailed explanations through a question-and-answer format  to help sponsors understand the regulat

The U.S. Food and Drug Administration (FDA) has issued guidance documents to help pharmaceutical manufacturers understand regulatory expectations related to market exclusivity for drug products  and responses to inspection findings following CGMP inspections . These guidances support transparency in regulatory processes and help industry ensure compliance with quality and development requirements. Guidance: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug

This blog summarizes two important regulatory guidances from the U.S. Food and Drug Administration (FDA) that support pharmacovigilance and real-world evidence generation: M14: General Principles for Planning, Designing, Analyzing, and Reporting Non-Interventional Studies E2D(R1): Post-approval Safety Data – Definitions and Standards for Management and Reporting of Individual Case Safety Reports Together, these guidances provide a framework for how pharmaceutical companies ge

The U.S. Food and Drug Administration (FDA) has issued a final rule titled “ Revising the National Drug Code Format and Drug Label Barcode Requirements .”  This rule introduces a uniform 12-digit National Drug Code (NDC) format  to standardize how drugs marketed in the United States are identified. The National Drug Code is an FDA standard used to uniquely identify drug products marketed in the U.S. Currently, the NDC assigned by FDA is a 10-digit number , and it may appear i

In February 2026, the U.S. Food and Drug Administration (FDA) issued a draft guidance for industry outlining considerations for using a Plausible Mechanism Framework  to develop individualized therapies that target specific genetic conditions with a known biological cause. The draft guidance, developed by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), describes how developers may generate substantial evidence o

Medical gases such as oxygen, nitrous oxide, and medical air are essential components of modern healthcare. Although they are widely used and often considered routine clinical supplies, these gases are regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Recognising the unique nature of these products, Congress created a dedicated certification pathway for Designated Medical Gases (DMGs)  under sections 575 and 576 of the FD&C Act. On 11 February 2026

In February 2026, FDA issued an updated guidance titled Computer Software Assurance for Production and Quality Management System Software , superseding the September 2025 version. In parallel, FDA released an updated Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions  guidance, reflecting the growing cyber risk associated with digital and connected medical technologies. Together, these guidances signal a shift awa

Artificial Intelligence (AI) is no longer a future concept in pharmaceutical research—it is already influencing how drugs and biological products are discovered, developed, manufactured, and monitored throughout their lifecycle. However, when AI outputs are used to support regulatory decisions , questions of trust, transparency, and accountability become critical. Recognising this, global regulators have begun defining expectations for the responsible use of AI in drug devel

As innovation in healthcare rapidly expands across digital health, medical devices, and advanced clinical trial designs, regulatory expectations must evolve in parallel. Recognising this shift, the US Food and Drug Administration (FDA) released and updated several key guidance documents in January 2026 , offering clarity on how emerging technologies and novel scientific approaches should be developed, evaluated, and regulated. These guidances collectively address clinical dec

The U.S. Food and Drug Administration announced the availability of a draft guidance for industry titled " M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality. " Prepared under the International Council for Harmonisation (ICH), this draft establishes a globally harmonized framework for organizing and presenting quality data in registration applications for human medicines. It updates the CTD's quality section to enhance registr

For generic drug developers, receiving tentative approval (TA)  for an Abbreviated New Drug Application (ANDA) is a major milestone—but it is not the end of the regulatory journey. Moving from tentative approval to final FDA approval  requires careful planning, timely submissions, and technically compliant study data. To support applicants, the FDA has issued two complementary guidance documents: ANDA Submissions — Amendments and Requests for Final Approval to Tentatively App

Safety reporting is one of the most critical safeguards in clinical trials involving investigational drugs and medical devices. To ensure that safety information is collected, evaluated, and communicated effectively, the U.S. Food and Drug Administration (FDA) has issued two complementary guidance documents: Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices   (December 2025), and Sponsor Responsibilities — Safety Reporting Requirements and

Clinical trials are the foundation for understanding whether a medical product is safe and effective. However, for many years, clinical trial populations have not fully reflected the patients who ultimately use these products in real-world settings. To address this gap, the U.S. Food and Drug Administration (FDA) has issued two complementary guidance documents: Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs  (Decembe

Developing a new drug is a long, expensive, and complex process. To make drug development more efficient and scientifically robust, the U.S. Food and Drug Administration (FDA) encourages the use of Drug Development Tools (DDTs) . These tools help sponsors generate better data, make informed decisions, and reduce uncertainty during drug development. To support this, FDA has established formal Drug Development Tool Qualification Programs, described on the FDA website Drug Deve

As biosimilars and interchangeable biosimilars become an integral part of modern biologic therapy, promotional communications around these products require heightened regulatory care. To address recurring industry questions and reduce the risk of misleading claims, the FDA has issued the guidance Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products . Published in 12 Dec