GlaxoSmithKline’s NDA for Breo Ellipta sought a COPD indication without prior approval of the combination product or its individual inhaled corticosteroid and long-acting beta agonist components in asthma. A broad development program with extensive dose finding won over a skeptical FDA.
A robust clinical development program allowed GlaxoSmithKline PLC to break with precedent and gain a chronic obstructive pulmonary disease indication for Breo Ellipta, a combination of an inhaled corticosteroid and long-acting beta agonist, without first obtaining FDA approval for the individual components and the combination to treat asthma.
The path of LABA and ICS/LABA products to a COPD indication historically has started with asthma because asthmatics have greater...
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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.
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
