News

The European Medicines Agency (EMEA) recently issued for public comment draft procedures on the evaluation of advanced therapy medicinal product (ATMPs).

The US Food and Drug Administration intends to automate and enhance the safety of the pharmaceutical supply chain by establishing electronic pedigrees (ePedigrees) for drug products.

Automation has been part of pharmaceutical processing for some time, but robotics have not yet found wide acceptance among drugmakers.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the May 2009 edition from Continental Disc and Filimatic.

The first project report on FDA's Sentinel website, discusses the evaluation of existing methods for safety signal identification.

Sanofi-aventis announced this week that it plans to construct a new vaccine-manufacturing center in Neuville-sur-Saône, France.

On May 7, 2009, as part of the President's fiscal year (FY) 2010 budget, the US Food and Drug Administration requested a budget of $3.2 billion, which is 19% more than the agency's current budget.

Also, Takeda to consolidate operations in Ireland; FDA to redesign website; Archemix names president and CEO; more...

Covance talks about the risks, challenges, and tests required to develop a pandemic vaccine.

Also, Oxford BioMedica forms collaboration with sanofi-aventis; FDA requires labeling changes for botulinum toxin producs; C. Richter King joins IAVI; more...

The US Food and Drug Administration issued a draft guidance for industry, Label Comprehension Studies for Nonprescription Drug Products, in the May 1 Federal Register.

Sanofi-aventis introduced this week its Biolaunch project at its Vitry-sur-Seine, France, pharmaceutical production site.

This week, pharmaceutical industry regulators and manufacturers moved quickly to address public health concerns regarding the outbreak and spread of H1N1 virus infection (swine flu). The following is an overview of key developments.

Pharmaceutical companies must make bold moves and "step outside of their sector" if they are to survive.

The president of BIO proposes the ingredients needed for industry growth.

Process steps, GMP documents, a purification vessel, and validation seem to disappear.

The Japanese government is eager to jumpstart its generic-drug market, but changes must come first.

Taiwan sees to bring its intellectual property laws and enforcment into better alignment with international standards.

The GDP committee of IPEC–Europe is trying to seal one more broken link in the supply chain. This article contains bonus online-exclusive material.

The organizations' presidents discuss market exclusivity, approval processes, and pending legislation.

With a new head of the FDA expected to be announced imminently, the pharmaceutical industry waits to witness the changes that will inevitably accompany the new appointment. These changes could, however, also impact the rest of the world's pharmaceutical markets.

This month, Frankfurt readies itself for the descent of more than 27000 additional visitors, as it plays host to the world's largest chemical engineering exhibition and congress - Achema 2009.

A novel cleanroom apparel design incorporates modern concepts to help minimize contamination. Take a tour of the design.

As the pharma industry desperately seeks to cut costs and streamline production, a new breed of CMO is growing in Europe. Find out how today's CMO is capitalizing on pharma's plant closures and divestments.

Also, Roche's Avastin trial does not meet endpoint; Innate Pharma names regulatory VP; more...

Senators Chuck Grassley (R-IA) and Ted Kennedy (D-MA) introduced legislation last Thursday that would give the US Food and Drug Administration more resources to inspect domestic and foreign plants that manufacture drugs and medical devices.

Global market research firm IMS Health issued a disappointing report last week regarding the state of the pharmaceutical market.

The Pharmaceutical Research and Manufacturers of America released a statement this week in response to recent media reports regarding the amount of pharmaceutical ingredients being discharged by manufacturing facilities into the environment.

The US Food and Drug Administration has agreed to address some core industry questions regarding the changes made to US Pharmacopeia General Chapter <467> in July 2008.

The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the common technical document (CTD) format, including the electronic CTD (eCTD).