Medical Device Network on MSN

The FDA’s GenAI proposal: evolving regulation for an evolved medtech era

The FDA's discussion paper around a proposed approach to GenAI-based medech regulation is open to stakeholder feedback until ...
JD Supra

AI Drug Development: FDA Releases Draft Guidance

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and ...
JD Supra

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device ...

Q&A: How FDA decision is speeding development of new osteoporosis drugs

Osteoporosis weakens bones and makes them more likely to break. The disease affects about 10 million Americans over age 50, ...
STAT

Concerns grow on safety issues tied to Neurocrine Biosciences rare disease drug

Patient advocates and some experts are expressing growing alarm over the perceived risks of a rare disease drug sold by ...
Medscape

FDA Aims to Streamline Biosimilar Drug Development

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
Healio

FDA aims to accelerate biosimilar development as way to reduce drug costs

Please provide your email address to receive an email when new articles are posted on . The FDA issued draft guidance that would streamline testing of biosimilars. A separate plan would eliminate ...
BioSpace

FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues

The FDA needs more time to review Novo’s investigational bispecific antibody for hemophilia A before making an approval decision, citing manufacturing issues as the reason behind the delay. The agency ...
RAPS

Hypertension Drug Development: FDA Draft Guidance Outlines Recommendations

The US Food and Drug Administration (FDA) on Friday issued draft guidance providing recommendations for sponsors looking to develop drugs to treat hypertension in patients already taking several other ...
RAPS

FDA issues draft guidance on mpox drug development

In a much-anticipated draft guidance issued on Thursday, the US Food and Drug Administration (FDA) said that unlike smallpox therapeutics, treatments for mpox cannot be developed under the Animal Rule ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...