On 3rd January 2018, Food and Drugs Administration (FDA) published a draft guidance detailing about the good practices for the submission of ANDAs (Abbreviated New Drug Application).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 Mentioned below … Continue reading Draft Guidance Detailing Good Practices For The ANDA Submission
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.
Have you received the email from FDA with NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS ?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emails to labelers (manufacturer /brand owner of the product ) notifying about the “NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS” . There are … Continue reading NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS