FDA’s Nextgen Portal to Submit Pre-Assigned ANDA Number Requests through the CDER

Prospective abbreviated new drug application (ANDA) applicants will be able to submit Pre-Assigned ANDA number requests via the CDER NextGen Portal.

For Applicants with account holder account will be automatically updated with this Pre-Assigned ANDA number request functionality.  To create a new account, go to the CDER NextGen Portal, under the “Sign In” section on the right of the screen, click “Sign Up” (next to “Don’t have an account?”) and follow the instructions.

Benefits of using the Portal for pre-assigned number requests:

  • Ease of Use: Submitting via the Portal is easy-company information can be pre-populated, and all information regarding submissions is in one place
  • Automated confirmation: Portal users can log in, initiate a request, and receive an automated confirmation of the request.
  • Historical record: Portal users can view all submissions at any time. The Portal organizes requests based on submission status to assist with navigating requests.

For more login assistance, please go to: CDER NextGen Portal FAQs

For additional information on submitting pre-assigned application number requests, please visit the Requesting a Pre-Assigned Application number web page.

Maximal Usage Trials Guidance for Topical OTC Drugs Finalized By FDA

The US Food and Drug Administration (FDA) finalized guidance on conducting maximal usage trials (MUsT) to support the inclusion of an active ingredient in an OTC monograph. (more…)

Two more countries Bulgaria and Cyprus to benefit from EU-US mutual recognition agreement for inspections

The US Food and Drug Administration (FDA) confirmed the capability of two additional European Union (EU) Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Bulgaria and Cyprus were included into the mutual recognition agreement between the EU and the US on 29 April 2019.


TGA Announced Labelling changes: information for health professionals

Quality Use of Medicines relies on clear medicine labels. To reduce medication errors, medicine labels need to be more consistent, with important information made more prominent and easier to read.

Therapeutic Goods Administration has introduced improvements to help bring Australian medicine labels up to date and align them with international best practice and are designed to be more consistent and more clearly convey important information. TGA thinks these changes may reduce medication errors.

FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines

The Food and Drug Administration (FDA) is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths.

These behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.