PharmExec

FDA Reveals New Guidance for Streamlining Biosimilar Development

The Biologics Price Competition and Innovation Act of 2009 created the abbreviated approval pathway that biosimilars rely on, and the FDA has approved 82 biosimilars to date, with the new guidance is ...
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 ...
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, ...
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 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 ...
JD Supra

FDA and CTTI Hold Joint Workshop on AI in Drug Development – AI: The Washington Report

On August 6, the Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held a joint workshop to explore “Artificial Intelligence in Drug & Biological Product ...
Healio

Q&A: FDA update to biosimilar approval process may reduce time, cost of development

Please provide your email address to receive an email when new articles are posted on . An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...
News Medical

Understanding the process of drug development CMC

When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...
News Medical

How consultants help accelerate drug product development timelines

Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...
PharmTech

Drug Digest: Outsourcing Partnerships Fuel Global Biopharma Discovery and Scale-Up

Strategic outsourcing utilizes external expertise to accelerate the biopharma pipeline, integrating specialized workflows that drive efficiency from discovery through early clinical trials. *Full ...