What are the difference between FDA 483 and Warning Letter?
Posted on27 Mar 2020
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483 observation or FDA 483 and warning letter seems to be same, nut there is difference between the FDA form 483 and... Read More
New Drug Approval Case Study: USFDA approval of Zeposia, delayed market launch likely due to COVID-19
U.S. Food and Drug Administration (FDA) has approved ZEPOSIA® (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple... Read More
US FDA halts the regular plant inspection due to Covid-19 spread
The US FDA announced that it will no longer be able to inspect domestic production facilities in wake of risk posed by... Read More
Gilead’s Epclusa receives US FDA approval to treat chronic hepatitis C infection for children ages 6 & older
US FDA has approved a supplemental New Drug Application (sNDA) for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for the treatment... Read More
Regeneron, Sanofi initiates clinical trial in Kevzara to treat COVID-19
Regeneron Pharmaceuticals and Sanofi have started a clinical programme evaluating Kevzara (sarilumab) in patients hospitalized with severe coronavirus (COVID-19) infection. Kevzara is... Read More
What is USFDA Emergency Use Authorization (EUA)?
Under Emergency use authorization USFDA allows unapproved medical products (e.g. pharmaceutical, biopharmaceutical, diagostic tests, medical devices etc.) to use in market. This... Read More
USFDA granted emergency use authorization to Thermo Fisher’s diagnostic test to detect COVID-19
Thermo Fisher Scientific, the world leader in serving science, announced that the US Food and Drug Administration (FDA) has issued an emergency... Read More
USFDA shooting up warning letters to marketers for Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
Center for Drug Evaluation and Research (CDER), of United States Food and Drug Administration have busy time in monitoring illogical claims made... Read More
Insight on Hikma and Glenmark’s Exclusive Licensing Agreement for Commercialising Ryaltris Nasal Spray in the US
Posted on28 Feb 2020
Tagsdrug licensing, Glemark outlicensing, Glenmark, global pharma licensing deal, Hikma, inlicensing in pharma, Ryaltris
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Hikma Pharmaceuticals PLC and Glenmark Specialty S.A., a Swiss subsidiary of Glenmark Pharmaceuticals, a global innovative pharmaceutical company signed of an exclusive... Read More
Case Study : Rx-to-OTC switch of Voltaren arthritis pain
In this article we will be understanding about the Rx-to-OTC switch of Voltaren arthritis pain. It is one of the drug which... Read More