NON-LATEX CONDOM LABELING MUST DETAIL EFFICACY RISKS, LIMIT USE
NON-LATEX CONDOM LABELING MUST DETAIL EFFICACY RISKS, LIMIT USE to latex-sensitive individuals in order to be marketed. FDA recently sent a letter to several firms developing non-latex, or "plastic," condoms informing them that labeling must indicate that although laboratory tests appear to demonstrate the devices' effectiveness against sexually transmitted diseases and pregnancy, efficacy has not been proven yet through clinical tests. Labeling also must state that the condoms are recommended only for individuals with latex sensitivities, according to industry officials.
More from Archive
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.