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Latest From Bowman Cox
Contracts US agency awarded as fiscal year 2017 came to a close include one to Nexight for a regenerative medicine standards development process, another to Lorenz to manage eCTD submissions – and 26 more for regulatory science R&D.
FDA commissioner underscores importance of restoring full production in Puerto Rico, where nearly 10% of all pharmaceuticals consumed in the US are made. Some plants have partially resumed operations under generator power, he notes, but the full recovery that at some point will be needed to prevent shortages will require restoring the island's power grid.
FDA has identified more than 40 high-priority drug products from at least five companies and is offering assistance to resume operations, including 'coordinating transport of certain critical drugs out of Puerto Rico.'
FDA looks to carve out a place for office-use compounding within Section 503B, the new framework created after deadly fungal contamination of products, while industry supports efforts in Congress to allow it under the traditional Section 503A.
A House committee has requested a briefing from Merck on the June 27 NotPetya malware attack that has impeded manufacturing operations, and on the pharmaceutical company's subsequent remediation efforts. Meanwhile, a pharmaceutical industry group is bringing experts together to brainstorm on cyber security best practices.
Pharmaceutical companies race to prepare manufacturing facilities in Puerto Rico, many of which date back to the 1980s and 1990s, for the arrival of Hurricane Maria.