The QMN Weekly Bulletin

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.

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.

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.

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.

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

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.

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.

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