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The FDA is planning a small pilot program to test how it handles nonclinical study data submitted electronically in SEND 3.1 format — a Clinical Data Interchange Standards Consortium (CDISC) standard the agency has moved towards to gather more study data. Read More
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Pfizer and Janssen said the FDA’s draft guidance on drug abuse and dependence labeling for prescription drugs and biologics is good but needs some tweaking.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