The Federal Trade Commission says it has filed a stipulated order in which Endo agrees not to enter into anticompetitive patent settlements with gener...
A Deloitte 2017 regulatory science outlook discusses drug quality metrics, off-label promotion, and medical device cybersecurity.
The Justice Department says Baxter is paying $18 million to resolve criminal and civil charges arising from production of sterile IV solutions in a fa...
FDA posts a response to three citizen petitions that offered recommendations on biosimilar nonproprietary naming policies culminating in its final gui...
Hogan Lovells attorneys outline 21st Century Cures Act provisions affecting combination products.
Novartis says its generic Enbrel cant go on sale until at least 2018 while a patent dispute with Amgen is heard in the courts.
An FDA-483 lists seven deviations from CGMP for active pharmaceutical ingredients at Indias Granules Omnichem.
FDA approves a FujiFilm Medical Systems PMA for the Digital Breast Tomosynthesis, as an optional software upgrade for its ASPIRE Cristalle digital mam...