Despite onerous requirements on applicants, the agency was happy to cut its own paperwork, writes Filter.Read More
The court ruled FDA acted within Congress' authorization, and decisions were supported by evidence. Read More
The court denied the stay mainly because Fontem waited too long to file the emergency motion.Read More
The limited product debut in the UK has received overwhelming recognition from users and commercial partners.Read More
The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies.Read More
The FDA has made several updates to the desktop Safety Reporting Portal (SRP) tobacco questionnaire.Read More
The agency says there are scientific issues unique to the Juul application that warrant additional review.Read More
Juul Labs also said the agency failed to consider the totality of Juul’s evidence of the public-health benefits of Juul.Read More
Juul Labs filed an emergency motion with the U.S. Court of Appeals as it prepares to appeal the FDA´s decision.Read More
Currently marketed Juul products must be removed from the U.S. market unless a U.S. court intervenes. Read More