Regulatory Oversight and Compliance

An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.

In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.

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

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

The agency issued guidance regarding common issues involved with the development of treatments for rare diseases.

FDA’s Center for Drug Evaluation and Research provides guidance on development plans for botanical drugs.

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

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FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.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

The trend towards personalized medicines in Europe requires a more integrated framework that regulates the approval of devices and diagnostics.

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

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general council, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.

Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.

Create an efficient global labeling strategy that is compliant with both electronic and paper-based package-insert requirements.

Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.

Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

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FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.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

A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.