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Pfizer is suing a Texas health agency for disclosing pricing and rebate information to state lawmakers, alleging the release violates state and federal laws on confidential data. Read More
Outsourcing facilities and states have faulted the FDA for sluggish progress toward finalizing guidance documents on drug compounding and the differences between state and agency inspection protocols, according to the U.S. Government Accountability Office. Read More
Pharmaceutical representatives in Chicago must complete a professional education course and be licensed before conducting business, following the unanimous passage of a new ordinance by the city council as part of its plan to combat the opioid epidemic. Read More
The FDA rejected Spectrum Pharmaceuticals’ Qapzola, a treatment for non-muscle invasive bladder cancer, the company said following receipt of a CRL. Read More
The European Medicines Agency published new guidance on whether less comprehensive data can be used to support a new indication for a previously approved orphan drug product. Read More
The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More
The FDA intends to review 90 percent of priority review ANDAs deemed complete within 8 months, according to the agency’s GDUFA II commitment letter. Read More