On March 30, 2012, the U.S. Food and Drug Administration (“FDA”) denied a request to ban the chemical bisphenol-A, commonly known as BPA, from food and drink packaging materials. The request, made by the Natural Resources Defense Council (“NRDC”), sought …
FDA Proposes Reclassification of Tuberculosis Tests
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. …