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The FDA issued warning letters to four firms for a variety of violations, including testing issues, invalidating out-of-specification test results without justification and the use of untested water in manufacturing. Read More
The FDA has denied a petition from Public Citizen seeking a temporary ban on approvals of new drug applications for opioids until the agency creates a review process to assess their risks and benefits. Read More
Pfizer and Janssen said the FDA’s draft guidance on drug abuse and dependence labeling for prescription drugs and biologics is good but needs some tweaking. Read More
House Speaker Nancy Pelosi (D-Calif.) is expected to release a drug pricing bill as soon as this week that would give the government the power to directly negotiate the prices of the nation’s most costly prescription drugs. Read More
Drug manufacturers are making progress toward the FDA’s goal of increasing access to investigational drugs outside clinical trials, the GAO says in a report released Monday. Read More
Trutek has filed suit in a federal court against Matrixx Initiatives, alleging breach of contract and patent infringement by Matrixx’s OTC nasal spray Zicam. Read More
An unregistered outsourcing facility’s failure to report details of more than 4,200 potentially serious adverse events related to compounded hormones drew the ire of CDER Director Janet Woodcock, who reminded outsourcing compounders that they must report serious adverse events to the agency. Read More