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Theqmnweeklybulletin

June 8, 2012

Vol. 4 No. 23

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Alexza CRL Followed 483 Citing Drug Storage, Training Lapses

Concerns about inadequate drug storage and quality training at Alexza’s Mountain View, Calif., facility were cited by FDA investigators just weeks before the company received a complete response letter (CRL) rejecting its combination product for agitation drug Adasuve, an FDA Form 483 states. Read More

EU Offers Step-by-Step Guidance on New Pharmacovigilance Regs

Drugmakers should have a structured and recognized methodology for assessing evidence in an adverse reaction report, taking into account such factors as clinical relevance, quantitative strength of the association and the exposure-response association, according to a draft European Medicines Agency (EMA) guideline. Read More

Devicemakers Call Out CMC Over New EU Labeling Requirement

Implementing a new labeling requirement by the EU’s Central Management Committee (CMC) on Medical Devices will raise devicemakers’ costs without any benefit to patient safety, industry association Eucomed says. Read More

Contract Pharmacal Gets Closeout to 2010 FDA Warning on Unapproved Products, GMP Issues

Contract Pharmacal has received a closeout letter, resolving a 2010 warning letter that advised it to hire a good manufacturing practice (GMP) consultant. Read More

J&J’s McNeil Unit Warned for Selling Unapproved Lubricant, MDR Lapses

Johnson & Johnson (J&J) subsidiary McNeil received an FDA warning letter on a variety of violations related to personal lubricants, feminine hygiene products and other consumer goods. Read More

Procedural Shortcomings at Novalung Plant Prompt Warning Letter

Lax documentation of testing failures and inadequate design history files for Novalung’s surgical Lung Assist device has resulted in an FDA warning letter for the German company. Read More

FDA Comes Down on Contamination Risks at Genentech Avastin Plant

Genentech may need to tune up manufacturing practices at a San Francisco, Calif., plant that makes cancer drug Avastin. Read More

China Shuts Down Gel Capsule Makers in Effort to Contain Chromium Scare

China’s State Food and Drug Administration (SFDA) instructed local regulatory authorities to shut down drug facilities manufacturing gelatin capsules contaminated with toxic levels of chromium. Read More