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February 01, 2016
The EU’s key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.
January 28, 2016
Amgen announces FDA will review the company’s BLA for ABP 501.
January 22, 2016
FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.
January 15, 2016
BioMarin Pharmaceutical announced FDA issued a complete response letter to dirsapersen, disclosing that the NDA was not approved.
January 14, 2016
FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility.
January 08, 2016
A US district judge entered a consent decree of permanent injunction on behalf of FDA, between the United States and pharmaceutical company, Downing Labs.
January 07, 2016
The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.
January 05, 2016
FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.
January 04, 2016
More “me-betters” and more focused breakthroughs could enhance new drug development.
January 02, 2016
The bio/pharmaceutical industry will face increased scrutiny of product quality and cost drivers.