JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
https//fedtechmagazine.com

FDA Takes a Big Step Forward With the Electronic Submission Gateway

The Food and Drug Administration’s science-based mission includes receiving, generating and reviewing a wealth of data and products from the vast array of manufacturers and firms that the agency ...
JD Supra

Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new ...

Celcuity Announces Completion of Submission of Its New Drug Application to the U.S. FDA for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

This NDA submission is an important milestone, and it brings gedatolisib one step closer to becoming available for patients with HR+/HER2- advanced breast cancer,” said Brian Sullivan, CEO and ...
MobiHealthNews

FDA's first Pre-Cert workshops give industry and agency a chance to talk

The road to FDA clearance for medical devices may change radically in the next year. Last summer, initial discussion began around implementing a pre-certification program for medical device companies, ...

Insight Molecular Diagnostics: GraftAssureDX FDA Submission Warrants Hold Rating

Insight Molecular Diagnostics Inc. is rated Hold due to upcoming catalysts & pending FDA submission for GraftAssureDx. Read ...

Nexalin Technology’s Q-Submission for Gen-2 SYNC Accepted by U.S. FDA for the Treatment of Alzheimer’s Disease and Dementia

Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced that the U.S. Food and Drug ...

Scilex FDA submission for ELYXYB acute pain treatment acknowledged

PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a $77.5 million market cap company known for its focus on non-opioid pain management products, reported that the U.S. Food and Drug ...