Food and Drug Administration
Stryker Interventional Spine announced the clearance of 510(k)s, United States Food and Drug Administration approval allowing the sale of two additional products in its portfolio.
The Allegan-based health and beauty products manufacturer Perrigo Co. (Nasdaq: PRGO) said Wednesday it has received final approval from the United States Food and Drug Administration for its abbreviated new drug application for morphine sulfate 100ml/5 percent oral solution.
Perrigo Co. announced that it has received final approval from the United States Food and Drug Administration for its abbreviated new drug application for calcium acetate capsules, the generic equivalent of Phoslo Gelcaps.
MichBio, the biosciences industry association in Michigan, announced today that it is visiting Capitol Hill Monday and Tuesday. The primary agenda item will be the pending User Fee reauthorizations — Prescription Drug User Fee Act and Medical Device User Fee Act (MDUFA) — as well as the new Generic Drug User Fee Act and Biologics and Interchangeable Products User Fee Act.
Ann Arbor-based Tangent Medical Tuesday announced submission of a United States Food and Drug Administration 510(k) application for its NovaCath Secure IV Catheter System, developed from extensive clinical research of health care worker and patient needs.
Perrigo Co. Tuesday announced it received Food and Drug Administration clearance to market and distribute infant formula that contains 100 percent partially hydrolyzed whey protein.
Food safety partners are launching a campaign to reduce food poisoning due to undercooked pre-prepared foods.
Allegan-based Perrigo Co. has received final approval from the United States Food and Drug Administration for its abbreviated new drug application for over-the-counter Minoxidil Foam, a generic version of Men’s Rogaine Foam
The Food and Drug Administration wants to know if there could be a link between the artificial food coloring and hyperactivity in children.
Terumo Cardiovascular Systems, an Ann Arbor-based subsidiary of Terumo Corporation of Tokyo, Japan, announced it has agreed to the terms of a consent decree with the U.S. Food & Drug Administration regarding quality system improvements at the company’s Ann Arbor plant.