Angie Drakulich was editorial director of Pharmaceutical Technology.
The United States Pharmacopeia announced that its implementation period for the USP-National Formulary General Notices statement requiring all manufacturers to conform to recently revised residual solvent standards in General Chapter 467 has been extended from July 1, 2007 to July 1, 2008.
The European Medicines Agency?s (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted 11 positive opinions, 3 of which are tied to similar biological medicinal products.
While recapping the past 30 years' innovations in pharmaceutical technology, it's also important to start preparing for the next 30 years. But staying ahead of the curve will be challenging.
June 21 (London)-The European Medicines Agency agreed to follow up with patients affected by Roche Registration Limited's (Basel, Switzerland) "Viracept" (nelfinavir), which was recalled earlier this month. The drug, an antiretroviral medicine used to treat HIV-1 infected patients older than three years, was recalled from the European market after it was learned that some batches had become contaminated with ethyl mesilate during manufacturing.
Washington, DC (June 14)-The US Department of Health and Human Services awarded two contracts totaling $132.5 million to Sanofi Pasteur and MedImmune to retrofit their influenza vaccine manufacturing facilities.
Rockville, MD (June 4)-Americans may soon have access to more information about the risks and benefits of the prescription and over-the-counter drugs they take. The US Food and Drug Administration is establishing an advisory committee to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public.
Global corporate citizenship can go a long way.
Trenton, NJ (May 18)-Pharmaceutical and medical technology companies in New Jersey have found a striking disparity between six high-demand occupations and the number of qualified workers to fill those positions, according to a report issued by the HealthCare Institute of New Jersey.
Basel, Switzerland (May 11)-Roche opened a new biotechnology production center in Basel today, just two years after beginning construction. The facility will manufacture "Avastin," a cancer drug that inhibits the formation of new tumor blood vessels.
London (May 1)-The European Medicines Agency launched a database designed to facilitate the exchange of information about compliance with good manufacturing practices.
