
FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.
Click the title above to open the BioPharm International March 2018 issue in an interactive PDF format.
over 8 years ago
FDA Heightens Drive for Transparencyover 8 years ago
Current Challenges in Bioprocesses Developmentover 8 years ago
Characterizing a Bioprocess with Advanced Data Analyticsover 8 years ago
Computerized Systems Validationover 8 years ago
Regulatory Role in Bio/Pharma Progressover 8 years ago
Poseidon Takes on the Pharma Supply Chainover 8 years ago
Identifying and Controlling CPPs and CMAsover 8 years ago
Employing Spectroscopic Tools in Downstream Process Controlover 8 years ago
Biologic NMEs Maintain Strong Presence in 2017 Drug Approvals





