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Boehringer Ingelheim should see an FDA decision on its idarucizumab blood-thinning antidote by October, following receipt of priority review late this week. Read More
ISPE’s quality metrics team has narrowed from 16 to five the number of metrics it will ask drugmakers to collect data on during phase two of a pilot program aimed at helping the FDA boost quality compliance. Read More
The Medicare program would have saved $251 million on DME infusion drugs over an 18-month period if the Centers for Medicare & Medicaid Services had stopped paying wholesale prices set more than a decade ago, the HHS Office of Inspector General says. Read More
The FDA plans to discontinue accepting paper submissions from drugmakers submitting promotional materials for prescription drugs and offers guidance on how to submit such information using the electronic common technical document. Read More
Israeli pharma giant Teva is offering $43 billion to acquire rival generics maker Mylan, following weeks of widespread speculation about a possible deal, but the deal may not go down easy. Read More
European regulators are looking to industry for suggestions on the best ways to get generic versions of topical drugs approved without having to conduct time-consuming and expensive clinical trials to prove bioequivalence. Read More
The FDA warned a Chinese maker of active pharmaceutical ingredients over data integrity lapses and other serious deviations from current good manufacturing practice. Read More
Less than a year after the FDA said it would begin focusing on quality metrics, ISPE has released the first data from a quality metrics pilot program designed to give the agency better insight. Read More
Biosimilars manufacturers are looking to the FDA for official guidance on several aspects of regulation, including naming and interchangeability. Read More
As Otsuka’s exclusivity protection for its blockbuster Tourette syndrome drug Abilify expired Monday, the FDA urged a federal judge not to grant the drugmaker’s last-ditch request for a court order blocking the agency from approving generic versions of the drug. Read More