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How To Register With The FDA October 18, 2019

The US FDA requires facilities who are engaged in manufacturing, processing, packaging or storing food pharmaceuticals, and medical devices sold in the United States to register with the FDA. Therefore, pharmaceutical and device manufacturers must list their facility and list the products. Companies must annual renew the registration and listings.  FDA US agent is required … Continue reading How To Register With The FDA .... Read More

Your FDA US Agent has established FDA secure email address ? October 1, 2019

FDA secure email address is mandatory requirement for receiving regulatory communications through CDER. Starting  from October  , abbreviated new drug application (ANDA) applicants with secure email accounts will begin receiving action letters (approvals, tentative approvals, complete responses) by secure electronic communication only as the U.S. Food and Drug Administration (FDA), including its Office of Generic … Continue reading Your FDA US Agent has established FDA secure email address ? .... Read More

Draft Guidance Detailing Good Practices For The ANDA Submission September 30, 2019

 On 3rd January 2018, Food and Drugs Administration (FDA) published a draft guidance detailing about the good practices for the submission of ANDAs (Abbreviated New Drug Application). This draft consists all of the important things to consider while submission along with highlighting the common deficiencies that may lead to a delay for approval. Mentioned below … Continue reading Draft Guidance Detailing Good Practices For The ANDA Submission .... Read More

FDA Drug establishment registration renewal 2020 (for calendar year 2020) is nearing, what should you know before renewal. September 18, 2019

FDA Drug establishment  registration renewal  2020   calendar year    will begin   from 1st October, 2019.  Drug establishments which are registered in the year  2019 must  renew the registration  between 1st October  to 31st Decemebr 2019 in order to avoid expiration of  drug  establishment registration. For establishments  submitted  their   initial, updated or annual registration  between  1st … Continue reading FDA Drug establishment registration renewal 2020 (for calendar year 2020) is nearing, what should you know before renewal. .... Read More

NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS September 6, 2019

Have you received the email from FDA with  NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS  ?  Here is the  detailed action plan for you.   FDA has started sending emails  to labelers (manufacturer /brand owner of the product )   notifying  about the “NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS” .  There are … Continue reading NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS .... Read More

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