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The goal of the FDA’s quality metrics program is to share quantitative data with global regulators about the state of manufacturing quality, CDER Director Janet Woodcock said. Read More
A Pharmacia & Upjohn plant was slammed with its second FDA Form 483 in five years for failure to investigate discrepancies and out-of-specifications results, inadequate annual product reviews, failure to follow written procedures and inadequate documentation for cleaning procedures. Read More
FDA reviewers will revisit Merck’s anesthesia drug sugammadex this week in its fourth review attempt, taking on safety concerns that originally tripped up the candidate in 2008. Read More
On Thursday, the FDA approved Gilead’s Genvoya, a once-daily complete regimen for adults and pediatric patients 12 years of age and older with HIV-1 infection. Read More
While there is no set timeframe for the release of FDA’s final quality metrics guidance, the agency has plans to recruit volunteers to conduct a “dry run” in the spring to test the collection and sending of data to the agency. Read More
French drugmaker Sanofi is looking to future-proof its diabetes franchise by in-licensing rights to a trio of next-generation diabetes medicines from South Korea’s Hanmi in a deal worth up to $4.2 billion. Read More
The FDA is now recommending a traditional approval pathway for development of antiretroviral drugs for HIV-1 infection, a major shift from the condensed process allowed since the epidemic was at its peak. Read More