Regulatory Oversight

It's better to catch costly mistakes in the laboratory before they reach the accounting department.

Poland's government aims to make the Eastern European country a biotech powerhouse.

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography drugs.

The management board of the European Medicines Agency has introduced a range of new measures to strengthen and extend its conflicts of interest policy for scientific-committee members and experts, as well as for members of the management board.

The decision by the Indian patent authorities to issue a compulsory license for a generic version of a Bayer anticancer drug engenders debate.

Failure to disclose info may work sometimes, but eventually every question will be answered.

Comparison of the top GMP deficiencies cited by the PIC/S Participating Authorities.

China's drug-distribution network has been a mess for years, but government reforms and industry focus are unveiling new opportunities for market order and growth.

On Mar. 12, 2012, FDA released a draft guidance document for industry direct-to-consumer television advertisements that describes FDA's plans for implementing predissemination review.

FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are approximately 50 such guidances planned.

In a world where product recalls can mean the end of a company, all batches must be perfect.

Brazil's generic-drug market is growing steadily.

The author reviews significant changes to GMP for excipients in the forthcoming American National Standard, including a risk-based approach to excipient manufacture, why new requirements were proposed, and their potential impact to excipient manufacturers.

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment.

FDA answers key questions about the October 2011 guidance on using physical–chemical identifiers in solid oral dosage products to help prevent and avoid counterfeiting.

FDA has released a draft guidance for API manufacturers in response to a 2008 incident in which heparin sourced from China was adulterated with oversulfated chondroitin sulfate, causing serious adverse reactions in patients.

The EMA has published a guideline that addresses the influence of patients? genetic variability on drug pharmacokinetics.

After months of anticipation, the Food and Drug Administration issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.

A nickel's worth of free advice to the competition could come at the expense of your bottom line.

The Asian nation is strategizing to take the lead over its regional competitors in pharmaceutical exports.

The FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites.

As part of the BRIC bloc with Russia, India, and China, Brazil is one of the world's leading emerging economies and is also considered by IMS Health to be one of seven pharmerging nations, which also include Mexico, Turkey, and South Korea.

Technology may expedite operations, but the absence of the human element could cost dearly.

The European Union market takes steps toward continuous processing and modular facilities.

Cleanliness is crucial, even if zapping and trapping is necessary to reduce product contamination.

Packaging is indeed headed to be a lead sector in the Asian pharmaceutical environment, but certain challenges must first be overcome.

The last in a series of eight case studies from the Product Quality Research Institute focuses on internal GMP audits.

The sixth in a series of eight case studies from the Product Quality Research Institute focuses on packaging line GMP optimization.

EMA Hosts Subgroup Analysis Workshop.

Until now, the industry has adhered to the tradition of producing three batches of product to validate its manufacturing processes. But FDA?s new process-validation guidance does not prescribe any number of batches that is necessary for compliance.