Consumers pay when drugmakers delay, finds study of over-the-counter drug exclusivity rules

Policies designed to encourage drugmakers to introduce over-the-counter (OTC) versions of previously prescription-only ...
FierceBiotech

5 Market Access Mistakes That Can Derail Your EU Orphan Drug Launch

The European market for orphan drugs presents many opportunities and challenges for pharma companies. With over 30 million people in the EU living with rare diseases, the demand for innovative ...
CNN

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

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
Wired

OpenAI and the FDA Are Holding Talks About Using AI In Drug Evaluation

The Food and Drug Administration has been meeting with OpenAI to discuss the agency’s use of AI, according to sources with knowledge of the meetings. The meetings appear to be part of a broader effort ...
Reuters

US FDA proposes new process to accelerate approval of drugs for rare diseases

Sept 3 (Reuters) - The U.S. Food and Drug Administration on Wednesday proposed a new process to streamline the approval of drugs targeting rare diseases with very small patient populations, including ...