FDA has launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analysed by the FDA during the drug approval
Head of Advanced Research Science/Medical WritingRegulatory ProfessionalsLondon, UK
- FULL TIME
Senior Regulatory Operations SpecialistRegulatory ProfessionalsEurope, Ireland, Dublin
- FULL TIME
EU/EMEA Regulatory Affairs ManagerRegulatory ProfessionalsEurope, Ireland, Dublin
- FULL TIME
Head of Regulatory LabelingRegulatory ProfessionalsCambridgeshire, UK
- FULL TIME
Regulatory Professionals is one of the fastest growing global integrated regulatory outsourcing providers with a network of 20,000 pharmaceutical professionals globally. Working exclusively within the regulatory functions of Pharmaceutical, Biotechnology, Medical Device, Consumer health / OTC and Diagnostics industries.
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FDA has approved the first video game-based treatment for ADHD created by Akili. The video game, called EndeavorRx, has been years in development and is approved for children between the ages of eight and 12 with certain types of ADHD. The game is used in conjunction with other treatments such as clinician-directed therapy, medication and education to treat
Merck/MSD has won an approval from the FDA for its Gram-negative antibiotic Recarbrio, as a treatment for hospital-acquired and ventilator-associated bacterial pneumonia. Recarbrio is a combination treatment comprised of imipenem, a carbapenem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor. Imipenem works to kill the bacteria associated with the infection while the other