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 ...
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 ...
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 ...
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 ...
Regulatory Affairs Professionals Society

FDA launches rare disease framework initiative

A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to ...
RAPS

ICH adopts E11A guideline to spur pediatric drug development

The International Council for Harmonisation (ICH) on Wednesday announced that its ICH E11A guideline, which establishes a harmonized framework for extrapolating drug development data from adult trials ...
European Pharmaceutical Review

FDA seeks feedback on new framework for rare disease drug development

The US agency proposes its new regulatory framework will holistically address the unique challenges of rare disease drug ...
Hosted on MSN

FDA To Streamline Approval Process For Generic Biological Drugs

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...
Applied Clinical Trials Online

FDA Launches Rare Disease Framework Initiative to Reimagine Drug Development for Small Patient Populations

The FDA has announced the Rare Disease Framework Initiative, a broad effort to build a new regulatory approach tailored ...
Yahoo Finance

Biopharmaceutical Manufacturing Process Validation: Understand FDA Guidance and EU Guidelines (Nov 17th - Nov 18th, 2025)

Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...