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Manufacturers of new biologics could receive up to eight years of exclusivity in 12 countries under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Barack Obama inked with 11 other countries in October, were publicly released Nov. 6. Read More
The European Medicines Agency outlines the basic steps companies should follow when conducting post-approval efficacy studies to ensure the data meet regulatory standards for EU member-countries. Read More
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