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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
November 01, 2021
Abbvie’s Vuity (pilocarpine HCI ophthalmic solution) is the first and only eye drop to receive FDA approval for the treatment of presbyopia.
The Pfizer-BioNTech COVID-19 vaccine is the first to receive FDA Emergency Use Authorization for use in children ages five to 11.
October 29, 2021
Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.
EMA’s CHMP concluded that a booster dose of Moderna’s Spikevax vaccine may be considered in people aged 18 and older.
Genentech’s Susvimo (ranibizumab injection) is approved for intravitreal use via ocular implant for the treatment of neovascular age-related macular degeneration.
Otsuka has submitted an initial marketing authorization application to EMA for vadadustat as a treatment of anemia associated with CKD in adults.
The National Institutes of Health (NIH), FDA, and fifteen private organizations are partnering together to form the Bespoke Gene Therapy Consortium.
MHRA has granted a license to Gedeon Richter for Ryeqo to treat moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
The panel voted 17 to 0 to recommend that FDA grant Emergency Use Authorization for Pfizer-BioNTech’s COVID-19 vaccine in children aged 5 to 11 years old.
October 28, 2021
FDA has worked to clarify how drug development can gain from tapping into information in health care systems and claims databases.