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Johnson & Johnson (J&J) and Cybertrust were the first organizations to be cross-certified with the SAFE Bridge Certificate Authority earlier this year, and SAFE-BioPharma Association President Mollie Shields-Uehling tells PIR two more “biggish” pharmaceutical players will join them by the end of this month.
Regardless of when, how or if the FDA ever strenuously enforces 21 CFR Part 11, regulated life sciences companies would be well-served to proactively approach compliance efforts with an eye on the business case, experts stress.
Merck has entered into agreements to purchase both Abmaxis and GlycoFi in a move the company said will increase its presence in the growing field of biologic drugs.
The pharmaceutical industry may be emerging from a sluggish decade for R&D with an increased focus on clinical trials in the past several years, according to a new study by the Tufts Center for the Study of Drug Development.