As more biologic drugs come to market, manufacturers will require improved bioprocessing technologies.
Switching grades of raw material late in the development cycle can be costly. Best practice says get it right at the beginning.
Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board.
There are significant differences between small molecules and biologics fill/finish capacity.
New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.
Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.
The agency creates an electronic central repository to facilitate drug safety assessment reports.
FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.
Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.