On March 16, 2012, the U.S. Food and Drug Administration (“FDA”) announced its issuance of a proposed rule intended to lower the regulatory classification for nucleic acid-based tuberculosis tests. These tests, which are currently classified as Class III medical devices, …
FDA Approves Boniva Generics
On March 19, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of generic versions of the drug Boniva (ibandronate). Boniva, manufactured by Genentech Inc., is a once-monthly tablet used in the treatment and prevention of osteoporosis in women. …