OR WAIT null SECS
July 12, 2016
The agency reviews hemophilia A, skin, and diabetes treatments, among others.
The agency completes its risk assessment of the blood cancer treatments.
July 11, 2016
The agency announced that it has completed the review of the GDUFA backlog one year ahead of schedule.
July 08, 2016
The agency says that the routine large-scale compounding of drugs that are exact copies of existing medications undermines the the drug approval process.
July 06, 2016
The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.
FDA cited Guangzhou Haishi Biological Technology Co., Ltd. with CGMP violations.
July 02, 2016
Agency guidance and industry standards aim to reduce lapses and improve quality operations.
June 24, 2016
The agency is following up on a February 2016 inspection of the facility that found GMP violations.
The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.
The agency has suspended recommendation of Riluzole Alkem due to flawed study results.