Compliance Consulting - We have a proven strategy for FDA compliance, which we will help you execute, that identifies compliance gaps and develops a risk-based corrective action plan, ensuring you will pass FDA inspection.Learn More
You are invited to attend our Free Webinar on Successfully Submitting a 505(b)(2) Application. The webinar has been postponed.
Blog & Updates
February 27, 2015
Adverse drug events are among the leading causes of death from approved pharmaceuticals, and illnesses and deaths from these events cost the healthcare system billions of dollars each year. As such, the Food and Drug Administration has regulations regarding the monitoring and reporting of them. Keeping track of these events is important because the full […]Continue Reading
February 20, 2015
Effective standard operating procedures are an integral part of effective the operation of a company. They help to ensure that all personnel are conducting procedures in a standardized manner. As such, it is important to understand how to develop effective ones. Responsibilities of Pharmaceutical Executives As part of updating and revising standard operating procedures, pharmaceutical […]Continue Reading
February 13, 2015
It is 2013, and app developers for smartphones are introducing apps almost daily that can do amazing things such as take a person’s blood pressure, measure their blood glucose, or take their pulse. Many of these apps, known as mobile health (mHealth) applications, stem from the wants patients to monitor symptoms of their disease or […]Continue Reading
February 5, 2015
The 505(b)(2) is a New Drug Application (NDA) mechanism which allows an applicant to seek approval for a drug product based on full safety and efficacy documentation, some of which may be from literature or conducted by others and for which the applicant does not have the right of reference. Created in 1984, it is […]Continue Reading
January 30, 2015
Over the past several years, the number of dossiers being submitted in electronic Common Technical Document format has increased in both the United States and the European Union. As such, pharmaceutical companies should understand this format. What is the Electronic Common Technical Document? The electronic Common Technical Document is a format used to submit information […]Continue Reading
The owner of TheFDAGroup.com will not be liable for any errors or omissions in this information nor for the availability of this information. The owner will not be liable for any losses, injuries, or damages from the display or use of this information.