Regulatory Authority Actions

Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.

FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

*This article is an opinion piece and does not necessarily represent the views of BioPharm International.

The company adds a few new arguments-as well as new stakeholder support-to its Citizen Petition on biosimilar naming.

FDA determined the celebrity’s endorsement of Duchesnay’s morning-sickness medication Diclegis was misleading.

The agency issues guidance for companies considering registering with FDA as an outsourcing facility.

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

FDA issues guidance regarding fees for drug compounding outsourcing facilities.

FDA and industry support global framework and collaborations to secure the supply chain.

This article discusses cleaning validation of equipment dedicated to the production of a single API.

The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.

The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.

FDA warns an Arkansas compounding company that it is in violation of the FDCA.

The bill would authorize spending of approximately $8.1 billion on transit projects through 2015 while legislators plan a long-term bill that could have implications for the pharmaceutical industry.

A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.

FDA releases a report that analyses why some diseases are lacking treatment options.

The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.

The agency requires early notification of potential drug shortages.