BioSpace

FDA’s One Trial Policy Not a Revolution but a Potentially Risky Evolution

Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been ...

FDA proposes new treatment approval pathway for ultrarare diseases

The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments ...
The American Journal of Managed Care

FDA Proposes New Approval Pathway for Individualized Ultra-Rare Disease Therapies

Today, the FDA issued draft guidance outlining a new regulatory pathway intended to help sponsors gain approval for highly ...
BioSpace

FDA’s Bespoke Pathway To Focus on Gene Editing and RNA-Based Treatments for Rare Diseases

The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay ...
Targeted Oncology

Key Considerations for the FDA’s Guidance on MRD End Point in Myeloma

In an interview, C. Ola Landgren, MD, PhD, delved into the details of the FDA's draft guidance on using MRD as a basis for ...
National Law Review

FDA Announces New Guidance and Exemptions Under Food Traceability Rule

The Food Traceability Rule establishes additional recordkeeping obligations for entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List (FTL). These requirements ...
Becker's Hospital Review

FDA unveils pathway for ultra-rare disease therapies

FDA unveils pathway ultra-rare disease therapies to approve gene-editing and RNA treatments when trials are unfeasible for small populations.
FoodNavigator-USA

FDA allergen threshold guidance could reduce liability for food brands

FDA allergen thresholds offer food brands science-based guidance on managing cross-contact risks and using advisory ...
MobiHealthNews

Should mHealth companies want FDA regulation?

(I would like to thank Dr. Deepak Ayyagari of Sharp Laboratories of America and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s ...
MobiHealthNews

In-Depth: Anticipating FDA Regulation of Pharmaceutical Apps

Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile ...

Phoenix NP Announces Expanded Access to FDA-Approved Wegovy (Semaglutide), Including Injection and Newly Available Oral Form, Through Its Arizona Telehealth Program

PHOENIX, AZ - February 27, 2026 - PRESSADVANTAGE - Phoenix NP, a women-focused telehealth medical practice based in ...