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July 07, 2020
The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.
July 02, 2020
It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.
There is much to learn from the COVID-19 pandemic, but future success may hinge upon the capacity for regulatory bodies to harmonize approaches.
EMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.
483s and Warning Letters Point to Inadequate Quality Oversight
The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.
July 01, 2020
FDA can better monitor quality production of domestic versus foreign firms.
EMA’s Committee for Human Medicinal Products (CHMP) has recommended that Kaftrio, a triple combination therapy for the treatment of cystic fibrosis, be authorized for marketing in the European Union.
The European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have announced an agreement that will enable the parties to share confidential information on COVID-19 medicines.
The European Medicines Agency (EMA) has recommended a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant.