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May 01, 2019
EMA has revealed that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results.
Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.
Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.
A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.
April 30, 2019
Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.
The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.
April 26, 2019
The Regulatory Affairs Professional Society (RAPS) has released an updated agenda for its forthcoming conference, RAPS Regulatory Conference-Europe 2019.
April 18, 2019
CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.
The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.
The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.