Regulatory Blog

Two notable guidance documents released in 2026 address distinct but equally important aspects of healthcare regulation. The first, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities, provides updated recommendations regarding the communication of healthcare economic and clinical information between manufacturers and healthcare decision-makers. The second, Intent to Exempt Certain Unclassified Medical Devices from Premarket Not

As genome editing technologies continue to advance, sponsors are increasingly developing innovative gene therapies targeting rare, serious, and life-threatening diseases. These programs often involve complex manufacturing processes, extensive nonclinical studies, sophisticated analytical testing, and lengthy clinical development timelines. To support more efficient development pathways, the FDA released the draft guidance, Leveraging Prior Knowledge in the Development of Huma

Bioequivalence (BE) plays a critical role in generic drug development by demonstrating that a generic product performs similarly to its reference listed drug (RLD). To support approval of an Abbreviated New Drug Application (ANDA), manufacturers must establish that the proposed generic product delivers a comparable rate and extent of drug absorption under similar conditions of use. The FDA’s updated guidances, Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Su

Human factors engineering focuses on understanding how users interact with medical devices and applying that knowledge to design safer and more effective products. The FDA explains that user interface design can significantly impact patient safety, as user errors may lead to incorrect treatment, delayed therapy, compromised medical care, or patient harm. Manufacturers routinely perform human factors assessments during device development to identify and mitigate use-related ri

The U.S. Food and Drug Administration (FDA) has issued Revision 1 of its guidance titled "Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations" (May 2026), prepared by the Office of Clinical Pharmacology within the Center for Drug Evaluation and Research (CDER). This revision supersedes part of the 2022 guidance on Food-Effect Bioavailability and Fed Bioequivalence Studies and consolidates current FDA thinking on when, why, and how fo

The U.S. Food and Drug Administration (FDA) continues to expand its regulatory focus on safer pain management, opioid risk reduction, addiction treatment innovation, and infectious disease drug development through multiple recent guidance documents. These guidances collectively highlight the FDA’s evolving strategy toward: Reducing opioid dependence Encouraging non-opioid therapies Supporting innovative pain treatments Strengthening benefit-risk assessments Advancing addictio

The U.S. Food and Drug Administration (FDA) continues to modernize clinical research and postmarketing safety monitoring through new guidance documents focused on digital health technologies and real-world safety evidence. In May 2026, FDA published two important guidance documents: Submitting Continuous Glucose Monitoring Data in Clinical Trials Postapproval Pregnancy Safety Studies Guidance on Continuous Glucose Monitoring (CGM) Data in Clinical Trials What is Continuous Gl

Patient-matched medical devices are becoming increasingly important in modern orthopedic surgery. These devices are designed specifically for individual patients using imaging data such as CT scans or MRI scans. The goal is to help surgeons position orthopedic implants more accurately during surgery and improve overall surgical planning. To provide clearer regulatory expectations for manufacturers, the U.S. Food and Drug Administration (FDA) published the guidance titled “Pat

Artificial intelligence (AI) is rapidly becoming an important part of healthcare, drug development, and regulatory operations. To modernize its internal systems and improve operational efficiency, the U.S. Food and Drug Administration (FDA) announced major upgrades to its AI infrastructure and data management capabilities. On May 6, 2026, the FDA announced the launch of Elsa 4.0, an upgraded version of its internal AI tool, along with the completion of a large-scale data plat

Human cellular and gene therapy (CGT) products are transforming modern medicine by offering innovative treatments for serious and life-threatening diseases such as cancer, genetic disorders, and chronic illnesses. However, the development and manufacturing of these therapies are often highly complex due to personalized production processes, advanced technologies, limited patient populations, and short product shelf-lives. To support innovation while maintaining product qualit

The traditional clinical trial model has long been associated with delays in data reporting, lengthy timelines, and inefficiencies in decision-making. Recognizing these challenges, the U.S. Food and Drug Administration (FDA) has taken a transformative step toward modernizing clinical research. This press announcement was released on April 28, 2026, marking a significant milestone in the evolution of clinical trials. The FDA introduced major steps to advance the implementation

The FDA continues to strengthen regulatory expectations across both pharmaceutical quality and medical device oversight, with two important draft guidances issued in April 2026. The guidance Establishing Impurity Specifications for Antibiotics (April 2026, Draft) and Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators (April 20, 2026, Draft) provide structured recommendations for industry and regulators. Guidanc

The regulatory landscape for advanced therapies and patient access in the United States continues to evolve, with the FDA issuing updated guidances in April 2026 that address both cutting-edge genome editing safety and patient access to investigational treatments . Together, these guidances highlight the balance between innovation, safety evaluation, and ethical access to therapies across the product lifecycle. The guidance Safety Assessment of Genome Editing in Human Gene

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