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.
New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.
FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.
FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.