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October 24, 2019
CHMP has recommended that Baqsimi (glucagon), a non-injectable treatment for severe hypoglycemia, be granted marketing authorization in the EU.
October 21, 2019
The agency announced it has approved 1171 generic drugs in fiscal year 2019.
October 17, 2019
Over a two-year period, FDA inspections at company facilities found repeat problems with quality systems including lack of written procedures, inadequate investigation of out-of-specification conditions and corrective and preventive action, and insufficient cleaning and cleaning validation.
Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.
A recently published European Medicines Agency (EMA) report has demonstrated that there are continued efforts being made across Europe to reduce the amount of antibiotics used in animals.
Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.
October 11, 2019
As the world awaits the outcome of Brexit, a presentation taking place at CPhI Worldwide in Frankfurt, Germany will delve deeper into the implications of each potential scenario on the pharma industry.
Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products due to a lack of assurance of sterility.
The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.
October 04, 2019
Glenmark Pharmaceuticals has been granted marketing approval from the Russian Ministry of Healthcare for its film-coated tablets, Montlezir, to treat seasonal and perennial allergic rhinitis.