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Theqmnweeklybulletin

Aug. 17, 2012

Vol. 4 No. 33

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MDUFA Passage Means Push for Changes to Device Policy

President Barack Obama signed the FDA Safety and Innovation Act, S. 3187, into law July 9, reauthorizing the Medical Device User Fee Act (MDUFA) and Prescription Drug User Fee Act, and creating new user fee programs for generic drugs and biosimilars. Read More

British Drugmaker Cited for cGMP, Misbranding Violations

British drugmaker A Nelson has been cited in an FDA warning letter after an inspection found glass fragments in a batch of the company’s Clikpak drug vials. Read More

Pharmacovigilance Audits Will Take a Risk-Based Approach, EMA Says

Drugmakers whose products are authorized in the EU can expect regular, risk-based and independent audits of their pharmacovigilance systems, and they should be prepared to communicate any safety risks with regulators and health professionals, according to two new guidelines related to the 2010 pharmacovigilance law that took effect July 2. Read More

CBER Plan Aims to Speed AE Analysis, Reduce Phase III Failures

FDA’s Center for Biologics Evaluation and Research (CBER) hopes to speed studies of biologic adverse events within the next five years by using the FDA’s Mini-Sentinel postmarket surveillance pilot in partnership with other government agencies and private organizations. Read More

Reports of Opioid Overfills Continue to Bedevil Hospira, Prompting Fresh Recall

Hospira is recalling another lot of hydromorphone HCl injection after receiving fresh reports of overfills in the syringe-based drug delivery system. Read More

Unapproved Wheelchair Cushions Top Multi-Issue Warning Letter

A Tennessee maker of wheelchair components received an FDA warning letter after the agency determined some products advertised on the company’s website had never been formally approved. Read More

Clinical Investigator’s Warning Won’t Trip Up First HIV Home Test Launch

An investigator has been warned for failing to comply with state laws, the study protocol and IRB requirements during a clinical trial of the first FDA-approved home HIV test, OraQuick. Read More

AngioDynamics Lacked Approval on Device Feature, 483 States

A Form 483 for AngioDynamics of Queensbury, N.Y., states the company distributed a range of devices with flaws or unapproved features. Read More