Regulatory Oversight and Compliance

The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.

Europe needs a more standardised and consistent approach for supplying excipient information to the regulators.

About one month after the announcement of McNeil Consumer Healthcare's recall of children's liquid pain and allergy medications , the US Food and Drug Administration testified before the US House Committee on Oversight and Government Reform about the issue.

Europe moves to place excipient GMP and GDP standards on the same level as active pharmaceutical ingredients.

Too much or too little control can actually lead to the same result.

The authors recommend a strategy for classifying similar nonstainless-steel surfaces into three groups based upon the analytical recovery that was observed in this study.

An effective quality management system will identify the root cause of non-conformances and put measures in place to ensure that they do not recur, but is the pharmaceutical industry choosing the right methods to make sure this happens?

Genzyme (Cambridge, MA) signed a consent decree of permanent injunction that requires the company to correct manufacturing-quality violations at its Allston, Massachusetts, manufacturing facility.

McNeil Consumer Healthcare is voluntarily recalling all lots that have not yet expired of certain over-the-counter children's and infants' liquid products.

Manufacturers will pay new fees but anticipate expanded drug use and safeguards for innovation.

The growth of Brazil's generic-drug market is on a fast track, but what are the projections for the sector's future?

A book helps statistics novices prepare to comply with the US Food and Drug Administration's draft guidance on process validation.

When vessels, seals, and cooling units go haywire, operators must get in the mix.

The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.

New Draft Guidance for Solid Oral Dosage Forms Focuses on Physical Chemical Identifiers. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

FDA made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers.

Genzyme provided an update on its manufacturing operations following the issuance of a draft consent decree by FDA regarding the company's Allston Landing, Massachusetts, manufacturing plant.

FDA Issues Warning Letter To Pfizer; And More.

An evaluation conducted by Ernst & Young assessing the effectiveness and efficiency of the European Medicines Agency has largely praised the agency; however, a number of strategic and operational recommendations for further improvements have also been made.

FDA Issues Warning Letters to Six US Medical Spas; and More.

Laboratory personnel share interesting tales as well as stories of unexpected tails.

As demand for global vaccine development and production grows, all eyes are turning to Asia.

FDA lacks resources to manage expanding postmarketing responsibilities.

In an attempt to strengthen safeguards against counterfeit, diverted, subpotent, misbranded, adulterated, or expired drugs, FDA issued a new final guidance for industry.

Biotechnology company Genzyme reported that FDA notified the company that it intends to take enforcement action to ensure that products are made in compliance with good manufacturing practice (GMP) regulations.