Orphan Drug & Orphan Drug Act
The Orphan Drug Act (ODA) provides for granting special status to a product to treat a rare disease or condition upon request... Read More
What is the significance of Black Box Warning?
Posted on29 Nov 2014
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A black box warning is the sternest warning by the U.S. Food and Drug Administration (FDA) that a medication can carry and... Read More
Wintac Limited to divest oncology marketing division to BPRL
Bangalore-based Wintac Ltd has decided to sell its trademarks and marketing division for the oncology products to Bangalore Pharmaceuticals & Research Laboratory... Read More
Who regulates pharmaceutical pricing in Indian market?
Posted on27 Nov 2014
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National Pharmaceutical Pricing Authority (NPPA), was established on 29th August 1997 as an independent body of experts as per the decision taken... Read More
180 day exclusivity could be granted to more than one applicant. Is it correct?
Observation is not correct. Generally 180 Days exclusivity is given only to the one company by USFDA. But innovator campnay holds the... Read More
What is 505(b)(2) applications?
505(b)(2) NDA allows drug companies to obtain Food and Drug Administration (FDA) approval of essentially “new” drugs without having to conduct the... Read More
First human trial of NIH-GSK Ebola vaccine shows promise
First results from a small phase 1 trial published yesterday in the New England Journal of Medicine show that a GSK/NIH Ebola... Read More
$1B Alliance Between Menarini, Oxford BioTherapeutics for Enhanced AML Treatment
Oxford BioTherapeutics and Berlin Chemie/ Menarini Biotech/ Menarini Ricerche (belonging to Menarini Group) announce that they have initiated the first-in-human clinical study... Read More
What is Form 483 in regulatory affairs?
Posted on27 Nov 2014
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Dr Reddy’s Laboratories has received inspectional observations from the US Food and Drug Administration (FDA) for one of its active pharmaceutical ingredients... Read More
GSK leads Access to Medicine Index 2014
The Access to Medicines Index published today has ranked GSK top for the fourth consecutive time. The Index is an independent measure... Read More