Standards & Regulation

Feb 27, 2015
By PharmTech Editors
FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.
Feb 26, 2015
FDA approved Actavis’ antibiotic Avycaz designed to combat drug-resistant bacteria.
Feb 25, 2015
Johnson & Johnson will pay $2.5 million to a plaintiff who developed gynecomastia after using Risperdal.
Pharmaceutical Technology: Feb 24, 2015
By PharmTech Editors
Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.
Pharmaceutical Technology: Feb 24, 2015
By PharmTech Editors
The company voluntarily recalls product due to FDA observations of potential sterility problems.
Pharmaceutical Technology: Feb 23, 2015
By PharmTech Editors
The agency cites Apotex’s Bangalore facility with quality system failures.
Feb 20, 2015
Celgene announced that its drug, Revlimid, gained FDA approval for the treatment of newly diagnosed multiple myeloma.
Pharmaceutical Technology: Feb 20, 2015
By PharmTech Editors
The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.
Pharmaceutical Technology: Feb 18, 2015
By PharmTech Editors
The company announces that FDA has closed out a 2012 warning letter.
Pharmaceutical Technology: Feb 17, 2015
By PharmTech Editors
FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.