In the pharmaceutical industry, primary and secondary patents are two important types of intellectual property (IP) protection that drug companies use to secure their innovations. They serve different purposes and provide varying levels of protection for a drug. “Big Pharma” companies rely on both primary and secondary patents to beat competition in the market. These […]
In the competitive world of pharmaceuticals, protecting innovative drug discoveries is not just a priority—it’s a necessity.This article explores composition of matter patents, a cornerstone of intellectual property protection in drug development, and their role in safeguarding pharmaceutical innovations. Composition of matter patents, also known as primary patents, are a key form of intellectual property […]
Brand-name pharmaceutical companies often employ various strategies to maintain their market share and delay the entry of generic drugs after the expiration of their patents. These tactics aim to minimize generic competition and protect the brand’s revenue streams, even after their exclusivity rights end from primary patents. These typically focus on leveraging brand loyalty by […]
In the high-stakes world of drug development, clarity and alignment can make or break a product’s journey to market. This is where the Target Product Profile (TPP) shines—a tool that ensures everyone is working toward the same end goal. What is TPP? A Target Product Profile (TPP) is a strategic planning tool/document introduced by the […]
Have you ever wondered what ensures the safety of the medications you take? Behind every prescription drug lies a detailed product label designed to protect patients and guide healthcare providers. A product label (or package insert) is a detailed document provided with prescription drugs that includes essential information for healthcare professionals to safely prescribe and […]
What is an NDA and What Does It Include? A New Drug Application (NDA) is a comprehensive submission made to the U.S. Food and Drug Administration (FDA) by a sponsor or manufacturer, requesting approval to market a new pharmaceutical product in the United States. The NDA serves as a formal request for the FDA to […]
The U.S. Food and Drug Administration (FDA) plays a vital role in guiding clinical trial sponsors through the drug development process. At critical stages, sponsors meet with the FDA to align on trial plans, review data, and prepare for regulatory submissions. Here’s a closer look at the key meetings, their timing, and their specific focus […]
A clinical trial can be stopped under specific circumstances, guided by predefined rules outlined in the trial protocol, and based on the ongoing assessment of participant safety, data integrity, and scientific validity. At times, the sponsor will ask to put the study on hold until they further investigate the issues. Stopping Rules in Clinical Trials […]
A Data and Safety Monitoring Board (DSMB) is an independent group of experts established to ensure the safety of participants and the integrity of data in clinical trials. The DSMB provides ongoing oversight to ensure that trials are conducted ethically and that the rights and well-being of participants are protected. Key Roles and Responsibilities of […]
Good Manufacturing Practice (GMP) is an essential part of Quality Assurance that ensures products are consistently produced and controlled to meet the quality standards appropriate for their intended use, as outlined by the Federal Food, Drug, and Cosmetic Act (FD&C Act). GMP encompasses the entire production and quality control process, including key areas such as: […]