OR WAIT null SECS
August 02, 2015
Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.
August 01, 2015
Create an efficient global labeling strategy that is compliant with both electronic and paper-based package-insert requirements.
July 31, 2015
Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.
Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.
“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.
July 28, 2015
FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.
July 24, 2015
The guidance provides recommendations for submitting analytical procedures and method validation data to FDA.
July 20, 2015
Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.
July 16, 2015
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.