March 14th 2025
The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
CDER to Expand Office of Generic Drugs
September 11th 2012As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.
Bristol-Myers Squibb Issues Voluntary Recall of Carmustine for Overfilled Vials
September 4th 2012Bristol-Myers Squibb has initiated a voluntary recall of 10 lots of BiCNU (carmustine for injection) previously manufactured by Ben Venue Laboratories, a former, third-party contract manufacturer for the company, to the user level.
Early Development GMPs for Stability (Part IV)
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
Janssen Pharmaceuticals to Pay $181 Million in Multistate Consumer-Protection Suit
August 31st 2012The Johnson & Johnson subsidiary Janssen Pharmaceuticals has announced a settlement and consent decree with 36 states and the District of Columbia in regards to previously disclosed allegations related to the company's marketing and promotional practices relating to Risperdal (risperidone).