Drugs

CDER NextGen Portal Pre-assigned ANDA Numbers

FDA has announced that later this month generic drug applicants will be able to submit pre-assigned ANDA number requests through CDER’s NextGen Portal. For sponsors already having a CDER NextGen Portal account, the account will be automatically updated with this pre-assigned ANDA number request functionality. To create a new account, go to the CDER NextGen Portal and 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. For more login assistance, go to: CDER NextGen Portal FAQs. For technical support, email CDER Platform Support at edmsupport@fda.hhs.gov.

FDA has outlined the benefits of using the portal for pre-assigned number requests. They are:

Ease of Use: Submitting via the portal is described as 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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome