The FDA is moving forward with digitalisation in all areas and the CDER NextGen Portal is a good example. What is the CDER NextGen portal? CDER’s NextGen Portal is a cloud based system for users to report information to the FDA. From Drug Development Tools (DDTs) to amendment submissions, stakeholders can utilise the NextGen Portal. …
Tag Archives: FDA
eSTAR – FDA’s next move to go digital
On 10th January 2023 the FDA announced a joint eSTAR, the electronic Submission Template And Resource pilot together with Health Canada. This is another approach in digitalisation via harmonising submission formats, allowing originators to reuse data and documents in different regions. The pilot will test the use of a single eSTAR submitted to both the …
New eCTD rejection criteria in force at the FDA
Marketing Authorisation Holders beware! The FDA has just announced that the Center for Drug Evaluation and Research (CDER) will begin rejecting submissions that fail eCTD validation checks 1551 and 1553. Both validation errors are of high severity as described in the eCTD Validation Criteria specification. The different severity levels can be summarised as follows: High: …
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FDA eCTD file formats updated
New opportunities for Pharma companies! Now Pharma companies can use audio and video files to support their promotional material during marketing authorisation applications, making the entire process more engaging. Over the last few months, the FDA has updated the file formats that are permitted within the eCTD. New formats have been added to the file …
FDA’s novel excipient pilot program is open for candidates
CDER (Center for Drug Evaluation and Research) recently launched a new voluntary Novel Excipient Review Pilot Program, intended to allow excipient manufacturers to obtain FDA review of certain ‘novel excipients’ prior to their use in medicinal products. This pilot is geared at fostering development of excipients that may be useful in scenarios in which manufacturers …
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FDA Guidance for Industry: Development of Abbreviated New Drug Applications during the COVID-19 Pandemic
In April 2021 the FDA released a new question & answer guidance document for the industry, specifically addressing Generics and their challenges during the COVID-19 pandemic. As the guidance is coming into effect immediately without prior public comments, it is worth having a closer look. The FDA has issued this guidance to provide general recommendations …
FDA Adverse Event Reporting System (FAERS)
FDA launches FAERS public dashboard for COVID-19 emergency use authorization products. Covid-19 is currently in the news worldwide and that on a daily basis. With vaccinations now becoming more widely available, not only healthcare professionals are interested in post vaccination information. The public too is getting hungrier not only for information on vaccination success, but …
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FDA’s eCTD end of life?
Action required: The FDA withdraws support for eCTD Module 1 US Regional DTD 2.01. FDA’s eCTD end of life? Not quite, but it looks like we are getting there. In October last year, the FDA announced the end of support for eCTD Module 1 US Regional DTD 2.01 for marketing applications. By 1st March 2022, …
Pharma Whisper 