Regulatory Blog

The US Food and Drug Administration (FDA) has announced its Fiscal Year (FY) 2027 Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives. The guidance outlines eight research areas intended to address scientific challenges in generic drug development, improve the efficiency of bioequivalence assessments, and accelerate patient access to generic medicines. The priorities were identified through collaboration with industry and public stakeholders, in

The US Food and Drug Administration (FDA) has issued Regulatory Considerations for Prescription Drug Use-Related Software, a guidance for industry addressing the application of drug labeling requirements to software developed or distributed by, or on behalf of, prescription drug sponsors. The guidance explains how FDA considers software-generated content presented to patients, caregivers, and healthcare professionals, and how this content should be addressed in prescription d

The US Food and Drug Administration (FDA) has issued two compliance policy guidances addressing requirements for blood establishments that collect blood and blood components, including Source Plasma. The guidance on Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements and the guidance on Blood Pressure and Pulse Donor Eligibility Requirements describe circumstances where FDA does not intend to take regulatory action

The US Food and Drug Administration (FDA) has published updated technical guidance documents addressing standardized electronic study data submissions and the electronic transmission of Individual Case Safety Reports (ICSRs). The Study Data Technical Conformance Guide – Technical Specifications Document and the E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide provide technical recommendations to support consistent data structures, electro

The FDA has issued two draft guidances in September 2026 covering important aspects of medical device regulatory submissions. One focuses on premarket submissions for robotically-assisted surgical devices (RASDs), while the other provides recommendations for the electronic submission of Premarket Approval (PMA) applications using the eSTAR template. These guidances highlight FDA's focus on structured technical evidence, software and cybersecurity considerations, clinical and

The U.S. Food and Drug Administration (FDA) has issued the September 2026 draft guidance “Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling”. The guidance provides recommendations for sponsors and applicants planning studies to evaluate how hepatic impairment affects the pharmacokinetics (PK) and, where appropriate, pharmacodynamics (PD) of drugs, including therapeutic biological products. It is a draft

Dental restorative materials and curing devices are important components of modern dentistry, and their safety and performance must be demonstrated before marketing. The U.S. Food and Drug Administration (FDA) has issued guidance documents describing recommendations for premarket notification (510(k)) submissions for dental composite resin devices and dental curing lights. The two guidance documents provide device-specific recommendations covering device description, predicat

Generative artificial intelligence (GenAI) is creating new opportunities for medical devices while also introducing regulatory challenges that may differ from traditional software and AI-enabled devices. The U.S. Food and Drug Administration (FDA) is seeking public input on how GenAI-enabled medical devices could be evaluated and monitored while maintaining reasonable assurance of safety and effectiveness. The FDA’s Center for Devices and Radiological Health (CDRH), through i

Therapeutic equivalence is an important consideration when evaluating multisource prescription drug products and their potential substitution. The U.S. Food and Drug Administration (FDA) uses therapeutic equivalence evaluations to determine whether certain approved drug products can be expected to have the same clinical effect and safety profile when used under the conditions specified in their labeling. The FDA has issued the Guidance for Industry: Evaluation of Therapeutic

Active immunotherapy products (ACTIMPs) are designed to treat existing diseases or conditions by inducing, stimulating, or modulating immune responses. Because their therapeutic effect depends on the interaction between the product and the immune system, demonstrating and maintaining product potency is an important part of development. The FDA has issued draft guidance on Potency Assessment of Active Immunotherapy Products, providing recommendations for developing and evaluat

Choosing the appropriate abbreviated approval pathway is an important consideration when developing a drug product for submission to the U.S. Food and Drug Administration (FDA). The pathway selected determines the type of information and data that can be used to support the application. The FDA has published the Guidance for Industry: Determining Whether to Submit an ANDA or a 505(b)(2) Application, which provides recommendations to help applicants determine whether a propose

As pharmaceutical products become more complex, the container closure system (CCS) plays an increasingly important role in maintaining the safety, quality, stability, and performance of a drug product. Packaging is not simply a means of containing a medicine—it can directly influence product quality through interactions between the drug, packaging materials, manufacturing processes, and storage conditions. The U.S. Food and Drug Administration (FDA) has issued the draft guida

Formal meetings between the U.S. Food and Drug Administration (FDA) and sponsors or applicants can play an important role at critical points in drug and biological product development. These interactions provide an opportunity for sponsors to obtain regulatory advice, discuss development challenges, clarify specific issues, and support efficient planning of development and regulatory submissions. The FDA’s August 2026 guidance, Formal Meetings Between the FDA and Sponsors or

As medical devices become increasingly sophisticated, ensuring that they are safe and intuitive to use is just as important as demonstrating their technical performance. Many device-related incidents are not caused by product failure but by use errors that arise from complex interfaces, confusing instructions, or challenging use environments. The U.S. Food and Drug Administration (FDA) has updated the guidance Applying Human Factors and Usability Engineering to Medical Device

As generic transdermal and topical delivery systems (TDS) continue to evolve, demonstrating bioequivalence extends beyond pharmacokinetic performance. Product adhesion, skin irritation, and sensitization are critical attributes that influence drug delivery, patient safety, treatment adherence, and overall therapeutic performance. To support the development of high-quality generic transdermal and topical products, the U.S. Food and Drug Administration (FDA) has issued two comp

As biosimilar development continues to advance, regulatory expectations extend well beyond demonstrating analytical similarity and clinical performance. Product presentation—including the container closure system (CCS) and device constituent parts—has become an important aspect of ensuring product quality, usability, and patient safety throughout the product lifecycle. The U.S. Food and Drug Administration (FDA) has published the draft guidance Biosimilar and Interchangeable

Appropriate eligibility criteria are essential for protecting trial participants while ensuring that clinical trial populations are representative of patients who are expected to receive the investigational therapy in clinical practice. Overly restrictive eligibility criteria may unnecessarily exclude patients, delay trial enrollment, and limit the applicability of study results. The three FDA guidances—Cancer Clinical Trial Eligibility Criteria: Laboratory Values, Cancer Cli

Hemodialysis blood tubing sets are critical components of the extracorporeal blood circuit used during hemodialysis treatment. Manufacturers submitting a Premarket Notification (510(k)) for these devices should provide sufficient information to demonstrate that the device is safe, effective, and substantially equivalent to a legally marketed predicate device. The Hemodialysis Blood Tubing Sets – Premarket Notification (510(k)) Submissions outlines recommendations for device d

As drug development continues to evolve, regulatory expectations are becoming increasingly focused on scientific rigor, product quality, and reliable clinical evidence. Two recently published U.S. Food and Drug Administration (FDA) guidances address important areas of pharmaceutical development—clinical investigations for psychedelic drugs and bioequivalence evaluation of topical dermatologic corticosteroids. While these guidances focus on different therapeutic areas, both em

Before submitting an Over-the-Counter (OTC) Monograph Order Request (OMOR) or advancing the development of an OTC monograph drug, early engagement with the U.S. Food and Drug Administration (FDA) can help sponsors clarify regulatory expectations, discuss scientific evidence, and address potential development challenges. Structured interactions with the Agency allow sponsors to obtain timely feedback, improve development planning, and support efficient regulatory decision-maki