USFDA Approval: Iluvien for diabetic macular edema
US ophthalmic drug specialist Alimera Sciences (Nasdaq: ALIM) says that the US Food and Drug Administration has approved Iluvien (fluocinolone acetonide intravitreal... Read More
What is Marketing Authorization Application?
Posted on25 Sep 2014
TagsEU, MAA, marketing authorization EU, new drug approval in EU, Validity of marketing authorizations
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Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval,... Read More
Boehringer Ingelheim and CureVac announce collaboration to develop next generation lung cancer immunotherapy
Posted on25 Sep 2014
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Boehringer Ingelheim obtains exclusive global rights for development and commercialisation of CureVac’s investigational therapeutic cancer vaccine CV9202 CV9202 is based on CureVac’s... Read More
Govt withdraws price control guidelines of 108 formulations
In a big relief to drug companies, the Narendra Modi government has thwarted a controversial move by a regulator to extend price... Read More
What is RCPA?
RCPA stands for Retail Chemist Prescription Audit. It’s a sales survey tool which is used to gather the competitor Knowledge. Retail chemist... Read More
What is the meaning of Brand Positioning?
Brand Positioning also called as Unique Selling Preposition. Brand Positioning is how a product is perceived in the mind of consumer in... Read More
Drug Regulations in India
Drug Regulations in India 1. Medicinal products in India are regulated by Central Drugs Standard Control (CDSCO) Organization under Ministry of Health... Read More
Difference between validation and calibration
Posted on18 Sep 2014
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A calibration is a process that compares a known against an unknown, whereas a validation confirms that the instrument is installed correctly.... Read More
What is meaning of Common Technical Document (CTD)?
The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be... Read More
What all information to be printed on the label of the medicine pack?
The following information is required to be printed on the label of a medicine under the Drugs and Cosmetics Act and DPCO,... Read More