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Biological Filing Process to FDA
Biologic filing is the process of submitting an application to the USFDA to request approval for a new biologic product. Biologics are a type of medicine that is made from…
Types of FDA Applications for Drugs and Biologics
The Electronic Common Technical Document (eCTD) is the standard, accepted electronic format for the following submission types: New Drug Application (NDA) Abbreviated New Drug Application (ANDA) Investigational New Drug Application…
Difference Between ICH and USFDA Guidelines
ICH and USFDA guidelines are two of the most important sets of regulations for the pharmaceutical industry. Both sets of guidelines aim to ensure the safety, efficacy, and quality of…
How to Prevent Medication Error?
A preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional or patient/consumer. Also…
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Osteoarthritis Management Guidelines
Osteoarthritis (OA) is the most common form of arthritis, and is a leading cause of disability among older adults. The knees, hips, and hands are…
COPD Management Guidelines
Chronic obstructive pulmonary disease (COPD) is a group of chronic lung diseases that block air flow in lungs, such as chronic bronchitis. Symptoms of COPD…
Diabetes Management Guidelines
Diabetes mellitus is a chronic metabolic disorder characterized by high blood sugar (hyperglycemia) in human body. This results from lack of insulin in the body…
Obesity Management Guidelines
The American Medical Association (AMA) designated obesity as a chronic disease and the World Health Organization (WHO) defines obesity as a body mass index (BMI)…
Asthma Management Guidelines
Asthma is one of the most common chronic disease. In which the reversible airways obstruction and bronchospasm occur and may produce extra mucus. This can…
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Frequently Asked Questions and Answers on cGMP
Q1. Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or…
Frequently Asked Questions on Data Integrity
This article contains a collection of frequently asked questions that have been submitted by the industry to the APIC DI…
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