Essential ANDA Checklist: Key Steps to Streamline Your Filing Process
Abbreviated New Drug Applications (ANDAs) are submitted to the FDA to seek approval for marketing generic drugs to the US market. As listed by the current FDA GDUFA requirements, sponsors must pay $252,453 to the FDA just to file an ANDA. This filing cost is set to increase to $321,920 in 2025. If the FDA […]
Vici Health Sciences Expands Staff and Footprint in Maryland to Meet Growing Customer Demands
Elkridge, Maryland–(Newsfile Corp. – October 8, 2024) Vici Health Sciences, a leading provider of pharmaceutical formulation, analytical, and regulatory services, is pleased to announce a significant expansion of its staff and physical footprint in Maryland. The expansion is in response to increasing demand for the company’s comprehensive pharmaceutical development services, enabling Vici Health Sciences to […]
Clinical Manufacturing Explained: How CDMOs Support the Development of FDA-Approved Trial Materials
The development of clinical trial material (CTM) is a critical phase in the pharmaceutical industry, especially in preparation for human clinical trials. Whether it’s an active pharmaceutical ingredient (API), placebo, or comparator drug, these materials must meet stringent FDA requirements to ensure patient safety and trial efficacy. Contract Development and Manufacturing Organizations (CDMOs) are key […]
NDA vs. ANDA: A Comprehensive Guide to Key Differences, Processes, and Regulatory Requirements
A New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA) are the two main pathways for getting drugs approved in the United States. For pharmaceutical companies, grasping the difference between NDA and ANDA is crucial for making smart product decisions. NDAs are intended for new drugs and require detailed clinical data to prove […]
Stability Chambers: Testing Methods, Essential Equipment, and Applications
Stability chambers are a must-have in pharmaceutical research and development. These chambers simulate precise environmental conditions to test the stability of drugs and other products in different settings. Here’s a closer look at the various testing methods used, the essential equipment involved, and how these chambers help maintain product quality and consistency in the pharmaceutical […]
Semi-Solid and Semi-Liquid Dosage Forms
Semi-solid and semi-liquid dosage forms are key pharmaceutical preparations that provide unique benefits for drug delivery. These formulations fall between the extremes of solids and liquids, combining properties of both states. They’re designed for external use, making it easy to deliver active pharmaceutical ingredients (APIs) right where they’re needed—on the skin or mucosal membranes. Types […]