News

The US Food and Drug Administration and the European Medicines Agency will collaborate in efforts that would allow drug companies to submit results of seven new drug-safety tests.

Senator Sherrod Brown (D-Ohio), member of the Senate Health, Education and Labor Pensions (HELP) Committee, is requesting additional information from the US Food and Drug Administration and the pharmaceutical industry, concerning the regulation and practice of outsourcing.

To choose the appropriate conveying system, a pharmaceutical manufacturer needs a thorough knowledge of the benefits and limitations of each conveyor type. The following overview compares several types of systems.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the June 2008 edition: Esco Technologies and Hawk Measurement

Manufacturers have stopped seeing disposable containment as an ad hoc solution, and the technology increasingly incorporates thoughtful design and engineering. The future promises to bring more changes and new applications for disposable containment technology.

The number of clinical-trial investigators overstepping their bounds has grown in the past few years. And, says Congress, the US Food and Drug Administration is taking too long to wrap up unresolved cases.

The European Chemicals Agency (ECHA), the European Union regulatory body overseeing the implementation of the REACH (Registration, Evaluation, and Restriction of Chemicals) regulation, began full operations on June 1.

In an assessment report about medicinal products containing heparin, the European Medicines Agency (EMEA)'s Committee for Medicinal Products for Human Use (CHMP) said it could not draw firm conclusions about the level of risk associated with unfractionated heparins (UFH) contaminated with oversulfated chondroitin sulfate (OSCS). Nevertheless, CHMP recommended that contaminated lots be withdrawn completely.

Also, Shire voluntarily recalls ADHD patch Daytrana

The steering committee of the International Conference on Harmonization and its expert working groups adopted Quality Guideline Q10 "Quality Systems" last week at a meeting in Portland, Oregon.

Also, Pall plans expansion in South America, Anthony Clarke joins Alexza Pharmaceuticals, more...

The US Food and Drug Administration issued a new guidance Monday on indexing structured product labeling. The Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research will begin indexing structured product labeling in the product labeling for human drug and biologic products.

The transatlantic cooperation of the European Commission, the European Medicines Agency, and the US Food and Drug Administration was recognized at the Second Meeting of the Transatlantic Economic Council, held mid May in Brussels. The TEC is tasked with overseeing and accelerating government-to-government cooperation to advance economic integration between the United States and the European Union.

The California Senate passed SB 1096 on May 29, voting to amend the state?s Confidentiality of Medical Information Act to allow pharmacies to provide third parties with patient information for the purpose of mailing prescription refill reminders and drug information directly to patients.

The US Food and Drug Administration advised patients, caregivers, and healthcare professionals to switch to hydrofluoroalkane-propelled albuterol inhalers now because chlorofluorocarbon-propelled inhalers will not be available in the US after Dec. 31, 2008.

The Synthetic Organic Chemical Manufacturers Association is evaluating proposed legislation, The Climate Security Act of 2008 (S. 3036), which directs the Environmental Protection Agency to establish a program for decreasing greenhouse emissions.

The global and US biotechnology industries performed well in 2007 as each recorded higher revenues and inched toward aggregate profitability.

As part of a larger effort to address drug counterfeiting, the European Commission is seeking to tighten manufacturing and related supply-chain requirements for active pharmaceutical ingredients.

Brief pharmaceutical news items for June 2008.

New products for sterile filling, quality control, and anticounterfeiting measures gained notice.

The authors focus on how single-use systems effectively control three potential sources of common contamination: cross contamination, microbial contamination and biologic contamination of the process facility.

Although the spotlight is now on nanoparticulate delivery for biologicals, other strategies have proven successful.

Scientists are uncovering signaling systems that operate via cannabinoid messenger molecules.

An ambitious survey of characterization techniques presents current information.

Ranjit Barshikar, GMP/Quality Consultant and former Vice President of Global Quality for Ranbaxy Laboratories analyses the past, present and future of Asia's pharmaceutical industry. Read more...

Last week, 2704 delegates representing 190 nations met in Geneva for the 61st World Health Assembly to set a global course for tackling new as well as longstanding threats to public health worldwide. The assembly?s biggest breakthrough focused on adopting a resolution that encourages research and development (R&D) as well as access to medicines for people living in developing countries, according to a World Health Organization (WHO) release.

University of Calgary biochemists used computer simulation in a new toxicity study to predict how "buckyballs," carbon-60 soccer ball-shaped nanomolecules, could damage animal cells.

The US Senate approved a measure (HR 2642) that would provide the US Food and Drug Administration with $275 million in additional funding under a supplemental appropriations bill. The measure now goes before the House.

Also, GVK BIO and Wyeth Pharmaceuticals form research agreement, Eli Lilly announces changes to management, more...

In a white paper published today, the US Food and Drug Administration described its Sentinel Initiative to create an electronic safety system that tracks drug performance.