Drug Delivery
FDA Inspects Hovione's Technology Transfer Center in New Jersey
Published in Medical Letter on the CDC and FDA, November 18th, 2007
The inspection was carried out by Ms. Joy R. Kozlowski-Klena Compliance Officer at the US FDA Center for Drug Evaluation and Research (CDER) and lasted 3 days, starting on October 9th and concluded on the 12th. No form 483 was issued. At the closing meeting, the inspector had several positive comments on our systems and indicated she would be recommending the approval of the site. This inspection covered the TTC's first commercial product - a high potency small molecule API for an injectable formulation. The NDA was filed last May and approval is...
Want to see the full article?
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Medical Letter on the CDC and FDA
More Articles from Medical Letter on the CDC and FDA
- Bioterrorism
Specialists in infectious disease and global health convene at Philadelphia meeting - Preventable Disease
Internists endorse 2007-08 adult immunization schedule and publish in Annals of Internal Medicine - Congestive Heart Failure
Palatin Technologies, Inc. Reports Initiation of Human Trials for the Treatment of Congestive Heart Failure - Heart Disease
Nebivolol Lowers Blood Pressure in African Americans With Stage I-II Hypertension as Demonstrated in a Study Published in the Journal of Clinical Hypertension - Heart Disease
UPDATE: Nebivolol Lowers Blood Pressure in African Americans With Stage I-II Hypertension as Demonstrated in a Study Published in the Journal of Clinical Hypertension - Anthrax
New anthrax research reported from I.J. Glomski and co-authors - More from this issue of Medical Letter on the CDC and FDA
NewsRx is Social
Follow us on your favorite social network by clicking on a button below:
Top Medical Newsletters
Awards
Best Health/Healthcare Content, 2012
Best Health/Healthcare Content, 2011
Best e-Business Site, 2010
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005
Facts & Stats
NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.
- Google 2010 PageRank: #2 Among Top Health News and Media Publications
- Google 2010 PageRank: #2 Among Top Science Publications in Biology/Physiology
- Google 2010 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
- Amazon's Alexa 2010 PageRank: #2 News and Media Site for the Pharmaceutical Industry
