The QMN Weekly Bulletin

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

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.

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.

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.

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.

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

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.

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.