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FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products March 14, 2020

Summary of  FDA guidance for alcohol based hand sanitizers (temporary policy)   FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products . Here is the summary of FDA’s temporary policy for hand sanitizers. Because of the public health emergency posed by COVID-19, FDA does not intend to take action against compounders … Continue reading FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products .... Read More

How to get DUNS number for free March 9, 2020

The  DUNS number is a  9 digit unique  number assigned by the D&B  (DUN and Bradstreet) which is  a private company. In this blog, we have explained “How to get DUNS number  for free. Why  DUNS number  ? DUNS number for drug establishment registration -Having a  DUNS number is a mandatory requirement for  drug establishment  … Continue reading How to get DUNS number for free .... Read More

FDA requirements for hand sanitizers (FDA regulations for hand sanitizers) March 4, 2020

Amid the novel corona virus outbreak COVID-19, we are getting many questions about FDA requirements for hand sanitizers  and other questions related to  FDA regulations for  hand sanitizers. FDA Regulations for Hand  Sanitizers   On 24th April, 2019 FDA published final rule stating that the three   active ingredients namely  benzalkonium chloride, ethyl alcohol, and isopropyl … Continue reading FDA requirements for hand sanitizers (FDA regulations for hand sanitizers) .... Read More

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

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