Regulatory Blog

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

As FDA continues to modernize and digitize its medical device review infrastructure, the updated guidance eCopy Program for Medical Device Submissions  plays a central role in transitioning industry toward fully electronic submissions. The December 2025 revision, reflected in the attached document, expands the technical requirements, clarifies the interaction between the eCopy and eSTAR programs, and incorporates contemporary digital standards needed to support efficient, err

The FDA has released two important guidances addressing very different but equally critical domains of drug development: the " nonclinical safety evaluation of monospecific monoclonal antibodies " and the appropriate inclusion of " QTc Information in Human Prescription Drug and Biological Product Labeling " . While one guidance focuses on modernising preclinical toxicology expectations for biologics, the other ensures that cardiac electrophysiology risks are clearly and consi

As pharmaceutical modalities diversify—from traditional injectables to complex biologics, cell therapies, inhalation products, and medical gases—the integrity of container closure systems, delivery devices, manufacturing components, and raw materials has never been more critical. The FDA’s recent guidances reflect this evolving reality and aim to tighten quality expectations across the entire product lifecycle. Three key guidances are: Current Good Manufacturing Practice for

The U.S. FDA has released a draft guidance titled Cross-Center Master Files: Where to Submit , issued in November 2025 addressing a longstanding challenge in regulatory operations: determining which FDA center  should host a master file (MF) when the file must support multiple regulatory submissions across different FDA centers. This guidance aims to reduce industry confusion, avoid duplicate submissions, and streamline review processes when MFs are used across drugs, biolog

The U.S. Food and Drug Administration (FDA) has released a final Guidance for Industry  yesterday (17 November, 2025) titled “ Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use ” that is intended to assist abbreviated new drug application (ANDA) applicants that reference a drug product intended for parenteral, ophthalmic, or otic use in seeking approval of a drug that is qualitatively (Q1) different

The U.S. Food and Drug Administration (FDA) has released its updated guidance “ How to Prepare a Pre-Request for Designation (Pre-RFD) ” , issued on November 6, 2025 . This guidance provides companies with a clear roadmap for obtaining early, non-binding feedback on the regulatory classification of their products — especially combination products , which often sit at the intersection of drugs, devices and biologics. The updated guidance strengthens transparency, clarifies ex

The U.S. Food and Drug Administration (FDA) has released a new draft guidance   titled “ Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies ”  (October 2025). This document represents a major shift in the FDA’s scientific and regulatory approach to biosimilar product development, particularly regarding when comparative efficacy studies (CES) may or may not be required

The U.S. Food and Drug Administration (FDA) has recently released two significant draft guidance  documents that mark important steps forward in the modernization and harmonization of medical device regulations: Quality Management System (QMS) Information for Certain Premarket Submission Reviews Menstrual Products – Performance Testing and Labeling Recommendations Both are designed to increase transparency, strengthen product safety and quality, and align FDA’s approach with

The U.S. Food and Drug Administration (FDA) continues to refine its regulatory guidance structure to ensure that patient experience, ethical access pathways, and robust data science converge effectively in modern drug development. Three cornerstone guidance documents released through 2024–2025 exemplify this integration — focusing on patient-focused drug development, expanded access to investigational drugs, and technical specifications for clinical trial data submissions. 1.

In a pivotal move to reduce avoidable regulatory delays, On October 23, 2025 the FDA has made public the internal filing checklists used by the Center for Drug Evaluation and Research (CDER) to determine whether a submitted application—such as a New Drug Application (NDA) or Biologics License Application (BLA)—meets the threshold of being “complete and reviewable.” By publishing these checklists, FDA aims to provide greater transparency , enabling sponsors to align better

The U.S. Food and Drug Administration (FDA) has finalized a pivotal guidance  addressing how the agency will decide when to begin and end...

On 25 September 2025 , the U.S. Food and Drug Administration (FDA) highlighted four critical updated or reaffirmed guidances  spanning...

On September 19, 2025, the U.S. Food and Drug Administration (FDA) released its revised draft guidance, “ Safety Labeling...

The U.S. Food and Drug Administration (FDA) released three important draft guidances  on September 11, 2025, providing updated...

The U.S. Food and Drug Administration (FDA) has released a new draft guidance " Development of Non-Opioid Analgesics for Chronic Pain "...