MD&M East

Ten Steps to Speeding Product Development While Meeting FDA Mandates

The path to successful product development for medical device companies is rife with roadblocks. The recession has only added to the pressures of mounting regulatory requirements, particularly those ...

Dr. Goodenowe Dietary Therapeutics LLC announces FDA-governed development pathway for nutrient-based compounds

Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...
The American Journal of Managed Care

FDA Q&A: Addressing Biosimilar Safety, AI in Drug Development, and Supply Chain Challenges

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...
Computerworld

FDA Revamping IT Development Process

The U.S. Food and Drug Administration has launched a project to overhaul its application development process to provide management with a view into the agency’s IT projects. The 12-month project, ...
Fox Business

AI and machine learning may speed drug development, manufacturing: FDA

The Food and Drug Administration (FDA) published a pair of discussion papers this week in an effort to outline areas artificial intelligence and machine learning may help in manufacturing ...
JD Supra

FDA’s Rare Disease Evidence Principles Process Provides Guidance for Applications Supported by a Single Pivotal Trial

On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...
The Scientist

FDA Proposes Speedy “Plausible Mechanism Framework” for Rare Disease Drug Development

New FDA guidelines for personalized genomic drug development are a step forward in advancing new therapies for ultrarare diseases, but industry leaders need further clarification.
DC Military

Navigating Medical Product Acquisition in FDA-Regulated Space

The execution of the U.S. Army Medical Research and Materiel Command’s mission to create medical products for the warfighter is intricate. A product manager must adhere to a long list of acquisition ...
WLKY

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
MD&M East

Top Mistakes in Medical Product Development

Creating medical technology products brings with it high risks and cost but can also generate huge rewards. Medical product development combines the challenges of creating systems with ...
News Medical

FDA grants Breakthrough designation to Dthera Sciences' development-stage product for Alzheimer's

Dthera ™ Sciences, the leading digital therapeutic company focusing on the elderly and individuals with neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has ...