FDA is the established ultimate authority for providing approval for manufacture of import of medical devices in US. The Congress also appoints it to charge certain fees for this...
US FDA Regulatory For Approval In Medical Devices
read more
Month: November 2016
Drug Establishment Registration Renewal
As per 21 CFR 207, companies who manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S are...
NDC Number
What is the NDC Number (National Drug Code)? NDC number is a 10 digit number grouped in three sets. NDC number has three components Labeler code Product code Pack code Labeler...
FDA Self Identification For The Year 2016 Started.
As required by Generic Drug User fee act FDA self identification period for fiscal year 2016 starts on May 1s 2015, and companies can self-identify their facilities till June...