Says phase III trials showed 'no unexpected safety findings'. Armed with new phase III data, GlaxoSmithKline (GSK) has said it is on course to file for approval of its rheumatoid arthritis candidate sirukumab in 2016. Sirukumab is an interleukin-6 (IL-6) inhibitor, and one of a crop of new drugs that GSK has said could add at least Â£6bn to its revenues in 2020. The drug has been partnered with Johnson & Johnson's Janssen Biologics unit since 2011.
Agencies covered by the FAC-P/PM program may require additional training and experience beyond the basic FAC-P/PM requirements. Additional training is training in support of the agencyâs mission or the requirements of a program and project managerâs specific position.
A Class III device that fails to meet PMA requirements is considered to be adulterated under Section 501(f) of the act and cannot be marketed. Premarket approval requirements apply differently to preamendments devices, postamendments devices, and transitional Class III devices.anufacturers of Class III preamendments devices are not required to submit a PMA until 30 months after the promulgation of a final classification regulation or until 90 days after the publication of a final regulation requiring the submission of a PMA, whichever period is later.