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US Agent for Medical Device Companies November 20, 2017

Pragmatic offer services to act US Agent for Medical Device companies. Responsibilities of US Agent for Medical Device companies. The responsibilities of the U.S. agent are limited and include: assisting FDA  to communicate with the foreign establishment, responding to questions related to  foreign establishment’s devices that are imported or offered for import into the United … 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

what you should know about GDUFA II April 19, 2017

In the month of August  FY 2018 fees for generic drug application will be published,  which will be based on GDUFA II. We have summarized highlights  of GDUFA II fee structure and how it will benefit small business.  GDUFA II Highlights   No fees for  ANDA supplement fees No facility fees for manufacturing  facilities with … Continue reading what you should know about GDUFA II .... Read More

U.S Agent Terms and Condition March 27, 2017

Pragmatic is private consulting firm and offers U.S Agent services to many companies. Pragmatic is not affiliated with FDA. By accepting this agreement, Pragmatic and Company agree to following terms. Company means the receiving party of services Pragmatic is acting as U.S Agent for Company to facilitate the communication between  FDA (US Food and Drug … Continue reading U.S Agent Terms and Condition .... Read More

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