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Wealthy nations with big pharma industries—in particular, Denmark, Germany, Japan, Australia and the U.S.—fought fiercely against the draft recommendation. Read More
Leading drug manufacturers and trade groups are calling for modifications to the FDA’s draft guidance on continuous manufacturing quality considerations. Read More
The FDA should publish a rulemaking notice on the roles that third-party companies play in the security of the nation’s drug supply “without delay,” the House Appropriations Committee said Monday ahead of a vote on the agency’s fiscal year 2020 budget. Read More
The guidance should strongly encourage sponsors to share “not only methods, practical aspects and results, but also subject-level data in a timely fashion,” Ionis said. Read More