Standards & Regulation

May 26, 2016
By Pharmaceutical Technology Editors
The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.
May 25, 2016
By Pharmaceutical Technology Editors
Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.
May 24, 2016
By Pharmaceutical Technology Editors
FDA cited BBT Biotech GMBH for failing to comply with current good manufacturing practice in its German API manufacturing facility.
May 19, 2016
By Pharmaceutical Technology Editors
The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.
May 18, 2016
By Pharmaceutical Technology Editors
The company recalls products due to sterility concerns.
May 17, 2016
By Pharmaceutical Technology Editors
The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.
May 16, 2016
By Pharmaceutical Technology Editors
FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.
May 15, 2016
Pharmaceutical Technology
Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.
May 12, 2016
By Pharmaceutical Technology Editors
The agency summarizes the results of its 10-year-long initiative to support small- and medium-sized enterprises.
May 12, 2016
By Pharmaceutical Technology Editors
The agency and national authority representatives talk about regulators’ role in keeping drug prices affordable.
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