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 1st ,2015.
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NDC (National Drug Code) is 10 digit number which is grouped in three sets. First set of five or six digits corresponds to labelar code, which FDA assigns to the labelar, such labelar code identifies the labelar or responsible owner of the drug.
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 required to register their facilities and are required to keep the information updated.
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 work from the license seekers. The fee is not fixed but is determined in the preceding year’s middle months.
In July ‘14 FDA in their compliance guidance for manufacture of drugs paid added attention to the NTDs. The Neglected Tropical Diseases. Most of these diseases are confined to the developing world and where the surroundings play an important role.
EDQM update their guideline for Revision and Renewal of CEP. The EDQM has revised the “Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs”.
FDA has published purple book containing list of licensed biological products with reference product, and biosimilarity. The lists includes the date on which biological product was licensed under PHS Act and whether FDA evaluated the biological product
FDA’s has made effective manual procedure and policy for communicating drug approval information. Considering interest of industry and FDA including press an other international counter parts FDA will make drug approval