Equipment design and cleaning procedures both play a role in thorough sterilization and cleaning.

At the request of FDA, the IOM prepared a report containing recommendations for how FDA might better monitor the safety of drugs after they have been approved.

Apple's experience with manufacturing facilities in China present opportunity for future best practice.

How niche strategies can offer mainstream potential for biopharmaceutical companies.

GlaxoSmithKline has partnered with the US?s Yale University to design a potential new class of medicines that could be beneficial in areas such as oncology, inflammation and infection.

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

FDA has issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine. FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.

In a move designed to increase its international presence, Watson Pharmaceuticals has agreed to acquire Actavis for EUR 4.25 billion ($5.6 billion).

GlaxoSmithKline has reached an agreement to divest certain over-the-counter brands in selected territories to South Africa's Aspen Pharmacare Holdings for approximately $264.7 million.

Merck KGaA has revealed further details about its previously announced restructuring program, including plans to eliminate approximately 580 jobs.

The European Commission is offering a EUR 2-million ($2.64 million) inducement prize to encourage innovation in the area of cold-chain logistics and vaccine stability.

FDA highlights success of CDER's drug-monitoring program.

A new report by FDA details the strategies, programs, and other activities the agency is using to address the rise of imported pharmaceutical products and APIs.

Amgen to Acquire KAI Pharmaceuticals; BASF, Catalent Enter into Bioavailability Collaboration; and More.

The European Medicines Agency (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials.

My network failed and I had to scrap my batch because my historian did not collect the required data. How do I upgrade the reliability of my network to maintain data continuity if my network fails again?

This month, CDER added a new program in drug safety to its "CDER World" platform for regulatory training and education.

Company makes bolt-on acquisition to enhance position in gout marketplace.

Illumina has sent a fourth letter to shareholders urging them to reject Roche's offer of $51 per share, which Illumina claims is opportunistic and undervaluing the company.

Amgen to Acquire KAI Pharmaceuticals; BASF, Catalent Enter into Bioavailability Collaboration; and More.

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

Johnson & Johnson announced this week that Sheri S. McCoy, vice-chairman of the Executive Committee, has resigned from the company. She was considered to be in line for the CEO position.

Generic-drug incursion and reduced demand contribute to modest gains.

As part of an ongoing collaboration into tabletting science, I Holland and the UK's University of Nottingham have launched a two-year programme to investigate the cause of tabletting sticking.

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.

An initiative in the UK will pump £75 million ($120.2 million) into translational science, with the aim of transforming biological understanding into clinical impacts that will benefit patients and the UK economy.

Ranbaxy Laboratories announced that beginning in March 2012, the first shipments of atorvastatin, the generic version of Pfizer's Lipitor, had been sent to US markets from its new Mohali manufacturing facility located in Punjab, India.

On Mar. 29, 2012, the Generic Pharmaceutical Association reiterated its call for Congress to move forward with user-fee proposals for generic drugs and biosimilar products.