Practical Guide to FDA Medical Device Submissions: 510(k), PMA and Exemption Pathways (WEBINAR)

The main market opportunities include navigating US regulatory pathways like 510(k), PMA, and DeNovo for medical device approvals. The modified 510(k) process encourages submission of new technologies ...

FDA Approval Process for Medical Devices Course: How to Make the Most of the FDA Pre-submission Process (June 30, 2026 and July 1, 2026)

The course offers key opportunities in understanding U.S. medical device approval pathways, including 510(k), IDE, PMA, and De Novo. It enhances practical skills through interactive case studies and ...
MobiHealthNews

FDA approval process too slow for wireless health

Montage is still awaiting FDA approval of its Wireless Healthphone, which is meant to send patient data wirelessly to doctors and other caregivers. Healthphone includes blood glucose monitoring ...
Hosted on MSN

FDA To Streamline Approval Process For Generic Biological Drugs

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...
Hosted on MSN

FDA unveils proposal for streamlined approval of customized drugs for rare diseases

Federal health officials in Washington announced a proposal on Monday aimed at accelerating the development of customized treatments for patients suffering from difficult-to-treat diseases, including ...
RAPS

New FDA Guidance Explains Process Behind Safety Labeling Changes for Drugs, Biologics

The US Food and Drug Administration (FDA) has released a new guidance document pertaining to labeling changes made to pharmaceutical and biological products based on new safety information discovered ...

FDA approves new weight loss pill in record time

A new daily pill to help with weight loss has been approved by the U.S. Food and Drug Administration (FDA), and it moved ...