Latest From Sue Sutter
CDER wants sponsors to use the NextGen Portal for electronic submission of promotional pieces to the Office of Prescription Drug Promotion, rather than sending in paper or physical media such as CDs; availability of this alternative pathway does not affect requirement for eCTD submission of some types of promotional materials starting in June 2021.
US FDA research finds consumer attitudes are more positive when animated characters personify drug benefits or sufferers, rather than representing the disease itself; OPDP staff also present research on consumer understanding of oncology endpoints and prescribers’ ability to detect deceptive ads.
A former senior leader in Johnson & Johnson’s medical devices business will take over the reins of the Biotechnology Innovation Organization from Jim Greenwood in June. McMurry-Heath – who also spent four years at the US FDA's device center as associate director of science – brings a resume that is long on scientific, regulatory and corporate experience, but she also has some political qualifications under her belt.
Recent panel review of biologics center's intramural research programs had its share of technical glitches and involved agency speakers blindly presenting to committee members they could not see; the experience suggests the difficulties an industry sponsor with an application hanging in the balance may face if a virtual advisory committee were to be held.
Use of alternative labs or imaging centers depends upon type of assessment and reason it is being performed, the US agency's revised guidance states; missed milestones for postmarketing studies required under accelerated approval will need to be justified.
Former senior leader in J&J’s medical devices business will take over the reins from Jim Greenwood in June; an immunologist by training, McMurry-Heath brings a resume that is long on scientific, regulatory and corporate experience, but she also has some political qualifications under her belt.