What is USFDA Purple Book? What it’s significance?
The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act... Read More
What is USFDA Field Alert Report (FAR) Submission?
FAR stands for Field Alert Report Submission. Submitting a USFDA Field Alert Report (FAR) is a critical process for pharmaceutical companies to... Read More
What is the meaning of summary of product characteristics (SmPC)?
A document describing the properties and the officially approved conditions of use of a medicine. Summaries of product characteristics form the basis... Read More
Is HEPA filters required to install for air supply in areas of non-sterile dosage forms?
No, HEPA filters does not specifically require manufacturing facilities for non-sterile drugs to maintain HEPA filtered air. The Regulations do require the... Read More
What is the meaning of Pharmaceutical Profiling?
Pharmaceutical profiling assays helps to measure the properties of large numbers of drug candidates at the earliest stages of discovery. It is... Read More
Importance of Key Opinion Leader (KOL) in pharmaceutical industry
Key Opinion Leaders are physicians who influence their peers’ medical practice, including but not limited to prescribing behavior. Other term which closely... Read More
What is USFDA Tentative Approval?
If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed... Read More
How to calculate compound annual growth rate (CAGR)?
Posted on29 Feb 2024
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The compound annual growth rate (CAGR) is a useful measure of growth over multiple time periods. It can be thought of as... Read More
What is 351(k) biologics license application (BLA)?
Posted on29 Feb 2024
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351(k) biologics license application is the biosimilar application process in USFDA. Manufacturers must submit 351(k) biologics license application (BLA) to have a product... Read More
What are the key factors which affect royalty rate in pharmaceutical industry?
Determining the ideal royalty payment in the pharmaceutical industry is complex and depends on various factors. Some key considerations include: Market Value:... Read More