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Theqmnweeklybulletin

Sept. 14, 2012

Vol. 4 No. 37

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Third-Party Manufacturing Concerns Draw Complete Response for Navidea’s Lymphoseek

The FDA sent Navidea a complete response letter (CRL) on its Lymphoseek injection, citing concerns over quality control at third-party contract manufacturing facilities. Read More

Cartoon-Friendly SOPs Lead to Higher Levels of Compliance: Experts

Succinct, simply worded standard operating procedures (SOPs) that can be expressed in cartoon or flowchart format lead to higher rates of compliance, pharma experts say. Read More

Ukraine Ratifies International Treaty to Root Out Counterfeit Drugs

The Ukraine late last month became the first country to officially ratify the 47-member Council of Europe’s Medicrime Convention — the first binding international treaty to deal with counterfeit drugs and their production. Read More

CDER Proposes Supersizing Office of Generic Drugs

CDER is looking to elevate the Office of Generic Drugs (OGD) into a “super” office, a move necessitated by the recent passage of the Generic Drug User Fee Amendments (GDUFA) and a heightened public focus on generic medicines, Center Director Janet Woodcock said. Read More

DPT Lakewood Warned Over Investigation Flubs, Sterility

DPT Laboratories’ investigations into batch failures at its Lakewood, N.J., plant are inadequate and heighten concern about microbiological contamination of topical drugs, according to an FDA warning letter. Read More

FDA Warning to Hospira Infusion Plant May Hint at Broader Problems

An FDA warning letter issued to Hospira’s infusion pump plant in Costa Rica may be emblematic of broader companywide manufacturing issues, analysts say. Read More

Lax Environmental Controls Draw Form 483 for Alliance Medical Products

Alliance Medical Products, a contract manufacturer of commercial and clinical drugs, failed to follow environmental monitoring plans in classified areas and storage rooms, an FDA Form 483 states. Read More

Eli Lilly Ad for Alzheimer’s PET Drug Draws Untitled Letter for Misleading Imagery

Eli Lilly has misbranded its radioactive PET drug Amyvid, approved for reviewing displays of brain scans using a black-and-white scale, by featuring a multi-colored brain image on a webpage advertisement and other promotional materials for the product, according to an FDA untitled letter. Read More