… vaccines and prescription drugs. FDA commissioner. On March 25, … s reorganization displaced all FDA communications staff and … , without notifying FDA, to notify FDA and provide safety … programs for prescription drugs, generics, biosimilars and medical devices, …

… have an outsized role in generics,” said Kurt Karst, a … and co-founder of the FDA Law Blog. “…Assuming these … this works?” Weeks after ordering FDA employees back into the office … reports. An internal email states FDA leadership is “allowing review staff …

… Food and Drug Administration (FDA) inspection for its Unit- … high-quality manufacturing for generics, as well as innovators … substance production. The successful FDA inspection ensures that the … passed its second consecutive FDA inspection with no observations. …

Amid the hard-to-follow cutbacks at the U.S. Food and Drug Administration, a little-known but important office was eliminated — and the implications will be felt not only by drugmakers, but consumers. The Division of Policy Development in the Office of …

… Jazz first got FDA approval for the drug … reverse payment agreements with generics drugmakers, hoping to … potential competitors include Hikma Pharmaceuticals, Amneal Pharmaceuticals and Lupin Ltd. … patent settlement agreements with generics developers are “pro- …

… . “Another example in generics and non-patented drugs … 125 million to produce essential generics, addressing shortages and price … more support. “The FDA’s Emerging Technology Program … Muradali said. “Also, the FDA’s Advanced Manufacturing Center promotes …

Pacira BioSciences, Inc. PCRX on Monday settled its litigations with Fresenius Kabi USA, Jiangsu Hengrui Pharmaceuticals Co., Ltd., and eVenus Pharmaceuticals Laboratories, Inc. related to patents for Exparel (bupivacaine liposome injectable suspension). …

… America Holdings, Inc., Takeda Pharmaceuticals U.S.A., Inc. … files for patent protection. FDA regulations recognize three distinct … at 405. The FDA thus requires generics to declare in … Counterstmt. 74. Several other generics, including Sandoz Inc., later …

… Monitoring potentially precedential FDA decisions for similar … within the ranks of FDA. FDA staffing cuts began … and gene therapies, complex generics, combination products and products … regulated areas, including FDA regulation, pricing and reimbursement …

… ’ Symbravo was approved by the FDA on 20 January 2025 for … rizatriptan are available separately as generics. The high cost of Symbravo …