OR WAIT null SECS
April 05, 2017
Deutetrabenazine is the first deuterated product approved by FDA, approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a decade.
March 29, 2017
The mAb is the first approved treatment that targets the progressive form of the disease.
March 28, 2017
The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.
March 21, 2017
FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.
March 16, 2017
FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.
March 15, 2017
The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.
March 13, 2017
Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.
March 07, 2017
The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.
Dr. Janet Woodcock said implementation of Informatics Process Management is a priority during the latest Director’s Corner podcast.
March 02, 2017
Policies limiting imports and immigration generate uncertainty for US and foreign firms