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FDA Registration September 16, 2018

Who is required to  comply with  FDA registration  requirements? Companies involved in  the manufacturing, processing  or packing of  Drug, Medical Device or  Food  are required to register with FDA .  However,  FDA registration requirements  vary based  on the operations performed by the establishment. 1. Drug Companies (OTC, Prescription, Bulk Drugs,  Pharmaceutical Testing  facilities) Drug establishment … Continue reading FDA Registration .... Read More

Food Facility Registration Renewal September 15, 2018

Biennial Food Facility Registration Renewal Requirements All  the registered  food facilities are required to renew their registration every even year between October to December, for example if you completed  food facility registration in the month of July 2017, your registration renewal  will be due in the month of December  2018 ,  which you can renew between  … Continue reading Food Facility Registration Renewal .... Read More

US Agent for Medical Device Companies November 20, 2017

US Agent for Medical Device companies. All the foreign medical device companies  who are required to comply with FDA registration requirements should appoint U.S Agent for communication with FDA.  US Agent acts acts as medium of communication between FDA and foreign company. Pragmatic offer services to act US Agent for Medical Device companies. Responsibilities of … Continue reading US Agent for Medical Device Companies .... Read More

FDA NO CHANGES CERTIFICATION OF PRODUCT LISTING November 10, 2017

Under 21 CFR 207.57(b), registrants must submit updated listing information at each June and December if there is change since the previous listing and they must submit this information to the FDA via electronic format, These changes include any drug recently introduced in the U.S. commercial distribution which was not previously listed, any drug which … Continue reading FDA NO CHANGES CERTIFICATION OF PRODUCT LISTING .... Read More

self identification for FY 2018 May 4, 2017

FDA’s self identification period for fiscal year 2018  starts from 1st May 2017 and all the facilities involved in generic drug submission are  required to submit, update or re-confirm the self identification on or before 1st June 2017. CDER has started to send  email with below content to all the facilities  who have self identified … Continue reading self identification for FY 2018 .... Read More

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