Regulatory Oversight

The agency provides recommendations for submitting proposed labeling with abbreviated new drug applications.

Managing change and overcoming employee resistance and fear requires a proactive approach.

An integrated approach can improve the efficiency of cleaning validation studies.

The agency releases guidance on the use of pharmacokinetics and pharmacodynamics analyses in the development of antibiotics.

The agency releases guidance on controlled correspondences related to generic-drug development.

Exports and domestic market have each been valued at more than US$15 billion.

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

FDA publishes the final Q3D Elemental Impurities guidance.

The agency releases guidance on the nonclinical evaluation of endocrine-related drug toxicity.

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.

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In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.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

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.

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.