UPDATED
Celltrion gets FDA approval for antibiotic generic
The South Korean company receives approval from the FDA for generic antibiotic, linezolid.
Archives for May 1, 2019
Waves of sartan recalls lead to new FDA draft guidance
The US FDA has issued draft guidance on the process of voluntary recalls, after a series of recalls involving sartan contamination with carcinogenic impurities.
Pharma’s dependence on legal departments, CROs to blame? ‘Common sense is completely gone out of research’
Clinical trials are less safe today as researchers are inundated with increasing amounts of data and new processes developed in part by CROs, which have created “tier upon tier of bureaucracy,” argues industry expert, who warns that things are getting...