data available to date do not suggest that RotaTeq is associated with intussusception.
Although all 28 people appeared to have clinically experienced an immediate hypersensitivity to an allergen, our postmarketing surveillance
could not demonstrate that the Cry9c protein was actually in the product consumed prior to the adverse health event.
The legislation also mandates that FDA require postmarketing surveillance
for devices that may cause serious injury or death or that are life-supporting.
'FDA Postmarketing surveillance
(PMS) activities have verified that the above-mentioned food products have not gone through the registration process of the agency and have not been issued the proper authorization in the form of a Certificate of Product Registration,' the FDA said.
The FDA said that based on its postmarketing surveillance
, the products Enle Drink, Peanut Milk Soup, Wei-Chuan Pickled Cucumbers in Soy Sauce, Haocailang Food, Samyang Hot Chicken Flavor Ramen Stir-fried Noodle-Carbo, Shang Biau Sichuan Soya Bean, and Ximivogue Food; did not undergo the registration process.
The approval requires Melinta Therapeutics to conduct a 5-year postmarketing surveillance
study to look for resistance to delafloxacin; the final report on that study must be submitted by the end of 2022.
Those include laboratory manipulation studies, pharmacokinetic studies, clinical abuse-deterrent studies, and postmarketing surveillance
. The clinical abuse-deterrent studies are the ones that test likability.
In response to this need, over the last several years there has been a steady increase in the number of regulatory requests/requirements for postmarketing surveillance
studies for new medications likely to be used by women of reproductive age or by pregnant women.
But it took 5 years of postmarketing surveillance
before that benefit was recognized.
At the meeting, speakers summarized postmarketing surveillance
data from Mexico, Brazil, Australia, and the United States for Merck's Rotateq and Glaxo-SmithKline's Rotarix.
provide an early examination of postmarketing surveillance
data from Brazil, one of the first countries to implement routine childhood immunization with Rotarix vaccine (I).