FDA Advisory Committee Calendar

Posted 13 December 2017 By Tarius

Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.

To contact the writer of this article directly, please send an email to sactracker@tarius.com.

Upcoming Meetings

Adcomm Calendar - December 2017

January 9, 2018 - Bone, Reproductive and Urologic Drugs Advisory Committee

The Committee will discuss a new drug  application for oral  testosterone undecanoate capsules,  submitted by  Clarus Therapeutics, for the proposed indication  of testosterone replacement in males for conditions associated with a deficiency or absence of  endogenous testosterone: Primary hypogonadism (congenital or acquired) and hypogonadotropic  hypogonadism (congenital or acquired).

January 10, 2018 - Bone, Reproductive and Urologic Drugs Advisory Committee

The Committee will discuss a new drug application for oral testosterone undecanoate capsules, submitted by Lipocine Inc. for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropichypogonadism (congenital or acquired).

January 11, 2018 - Antimicrobial Drugs Advisory Committee

The Committee will discuss a new drug application for ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.

Share this article:

Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Over the counter drugs, Postmarket surveillance, News, US, CBER, CDER

Tags: AdComm, FDA Advisory Committee, FDA Advisory Committee Calendar, FDA Advisory Committee Meetings, FDA Scientific Advisory Committees

Regulatory Exchange: Latest Updates From the Community