FDA sends Warning Letters to Cao Medical Equipment Co., Gentech and Hybrid Pharma.
FDA approves a Slayback Pharma ANDA for a generic form of Amags Makena.
FDA releases an FDA-483 with 11 observations from an inspection at the Intact Pharmaceuticals outsourcing facility.
Adamis Pharmaceuticals files a 505(b)(2) NDA for its naloxone pre-filled single dose syringe product candidate, indicated for treating opioid overdose...
FDA partially grants an Allergan petition seeking added bioequivalence assurances for irritable bowel syndrome drug Linzess (linaclotide).
FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren describe two additional FDA actions to spur medical device innovation.
FDA issues the latest six-month update of its list of off-patent, off-exclusivity drugs without an approved generic.
FDA posts interim acceptable levels of nitrosamine impurities in angiotensin II receptor blockers.