There are significant differences between small molecules and biologics fill/finish capacity.
New designations lead to faster drug approvals, but there is more work to be done.
Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board.
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.
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.
The agency creates an electronic central repository to facilitate drug safety assessment reports.