Regulatory Oversight and Compliance

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?

Operator attention to detail and adherence to procedures are crucial for proper cleaning.

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

EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts.

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

The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.

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In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.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FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.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.