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In the wake of an avalanche of FDA warnings to Indian drugmakers, Dr. Reddy’s Laboratories is the latest to be hit for GMP deficiencies at three of its Indian sites. Read More
AstraZeneca has agreed to buy San Mateo, Calif.-based ZS Pharma, a seven-year-old company whose hyperkalemia candidate ZS-9 could prove to be a blockbuster, in a deal valued at about $2.7 billion. Read More
Members of an FDA advisory committee unanimously recommended Merck’s anesthesia candidate sugammadex for approval, a win for the drug giant, which saw the candidate previously held back over safety and data integrity concerns. Read More
To spur greater mutual inspection reliance between the FDA and EU, the agency and Congress are working to grant the EMA access to unredacted inspection reports. Read More
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