Company will meet with FDA to determine a path forward now that the agency has issued a “complete response” letter for progesterone vaginal gel 8% for reducing the risk of preterm birth in women with a short cervix, Watson CEO Bisaro says.
Allergan PLC intends to discuss with FDA whether the accelerated approval pathway could provide a regulatory lifeline for progesterone vaginal gel 8% for reducing the risk of preterm birth now that the agency, as expected, has issued a “complete response” letter.
During a Feb. 27 analyst conference presentation, Watson President and CEO Paul Bisaro said the company intends to meet with...
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.’
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
