by inpharmedia | Nov 18, 2023 | Blog
The Food and Drug Administration (FDA) is the federal system that approves any drug related to humans. The Agency provides the sufficient information that enables the sponsors and industry to gather the data and requirements from time-to time. These data can be used...
by inpharmedia | Oct 24, 2023 | Blog
Every product should have a sufficient level of quality to ensure its efficacy and safety. The impurities/degradation products are the ones that arise during different stages of synthesis, manufacture and storage. They should be controlled at certain level to maintain...
by inpharmedia | Sep 9, 2023 | Blog
Any drug substance or drug product has to maintain the same quality, safety and efficacy throughout the lifecycle of a product. Generally, the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such...
by inpharmedia | Feb 3, 2023 | Approvals, Blog, Regulatory
The U.S Food and Drug Administration (USFDA) has approved 04 new drugs in the month of January. Out of the 04 approvals, 03 are NDA and 01 is BLA. LEQEMBI ITEMDESCRIPTIONNDA/BLA Number:761269Applicant/Holder:EISAI INCAPI:LecanemabDosage...
by inpharmedia | Jan 9, 2023 | Blog
The Lifecycle of a Drug (Pharmakon) or Biologic is initiated to address a disease or an ailment for which there is unmet clinical need or to improve existing therapies. The Process involved in developing a new drug from initial idea to the marketing of a...
