
USP is working to ensure quality standards and to increase public information.

IP rights and levels of innovation have opened a bit of controversy regarding decisions being made by Indian courts and legislators.

As technology advances, industry's needs are growing.

Scientists and practitioners must work together for the overall good of the patient.

Drug manufacturers have to be more than just "audit ready."

Remaining calm, cool, and collected during mergers and inspections is a feat in itself.

Merck and AstraZeneca Tackle Cervical Cancer and Tuberculosis.

Connecting science and policy might increase support for innovation.

There has been increasing cooperation between the EMA and the FDA in recent years, and this looks set to continue in the future.

The UK's coalition government has unveiled its spending review and it's good news for the life sciences sector, which has been allocated annual public funding of £4.46 billion ($7 billion) until 2014/2015.

A European pilot initiative will test the impact of consultations with a number of stakeholders such as patient representatives and payers on early stage drug development.

PPD and Bend Research Form Collaboration; Ricerca Makes Senior Appointment; And More.

The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.

Genzyme has outlined why it believes sanofi-aventis's tender offer of $69 per share "dramatically undervalues the company" and why a price of $89 per share would be more reflective of the company's true value.

The US Pharmacopeia (USP) has announced two new collaborations.

Puerto Rico's Governor Luis Fortuno unveiled a fiscal reform package in Puerto Rico this week as part of economic development and budget-deficit reduction plan for the commonwealth.

A European pilot initiative will test the impact of consultations with a number of stakeholders such as patient representatives and payers on early-stage drug development.

Pfizer Forms Pact with Biocon; Baxter Makes Appointments; And More.

During Oct. 5-12, 2010, more than 40 countries cooperated in an international week of action to combat the online sale of counterfeit and illegal drugs and to raise awareness of their associated health risks.

Presentations Available from ICH Quality Workshops

The European Generic medicines Association (EGA) has made a number of recommendations on how to ensure the quality of medicines in the globalized supply chain; in particular, the EGA spoke about API quality and quality supervision, and how these can be improved by transparent communication between authorities and industry.

The US Food and Drug Administration has posted on its website the minutes of the PDUFA V reauthorizaton stakeholder meeting.

GlaxoSmithKline (GSK) has provided further details concerning its new unit dedicated to rare diseases, which was launched in February.

Jeffrey Hartry, director of quality systems and information at Cangene (Winnipeg, Canada), talks about his company?s conversion from a paper-based to an electronic training-management system.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2010 edition from EMD Millipore and Sartorius.

An expert-panel-written book has surprising shortcomings.

Restructuring at sanofi-aventis will result in the elimination of approximately 1700 jobs in the US — about 25% of the company?s US Pharmaceutical Operations division workforce.

ICH Workshop Addresses Quality Systems.

sanofi to Cut 25% of US Workforce; AMRI Names VP of Chemical Development; And More.

The US Food and Drug Administration has released an implementation report on its Regulatory Science Initiative. The report outlines the agency's plans to advance regulatory science through new tools, standards, and approaches for assessing the safety, efficacy, quality and performance of FDA-regulated products, according to an agency press release.