FDA Paves Way For Pfizer COVID-19 Vaccinations In Young KidsThe FDA cleared kid-size doses — just a third of the amount given to teens and adults — for emergency use, and up to 28 million more American children could be eligible as early as next week.
Moderna Seeks Full Authorization For COVID-19 Vaccine, Will Send Data To FDAModerna wants full approval from the Food and Drug Administration for its COVID-19 vaccine.
206 Million Eggs Recalled Over Salmonella ConcernsMore than 200 million eggs distributed to restaurants and grocery stores in nine states have been recalled because of bacterial contamination.A notice posted on the Food & Drug Administration website Friday said the eggs shipped from a North Carolina farm may be tainted with salmonella. The bacteria can cause nausea, diarrhea and, in rare cases , death. Twenty-two illnesses have been reported.
FDA Proposes Ban On Indoor Tanning For MinorsThe proposal would also require tanning bed users to sign consent forms acknowledging the risks of the radiation-emitting devices.
Stryker Interventional Spine Launches Two New ProductsStryker 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.
Perrigo Launches Morphine After FDA ApprovalThe 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 Receives FDA Approval for Calcium Acetate CapsulesPerrigo 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 to Visit Capitol Hill on Pending User Fee ReauthorizationsMichBio, 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.
Tangent Medical Seeks Approval Of New Catheter SystemAnn 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 Gets FDA Nod To Sell Store Brand Version Of Good Start Gentle Infant FormulaPerrigo Co. Tuesday announced it received Food and Drug Administration clearance to market and distribute infant formula that contains 100 percent partially hydrolyzed whey protein.
Consumers Urged To “Cook It Safe” When Preparing Convenience FoodsFood safety partners are launching a campaign to reduce food poisoning due to undercooked pre-prepared foods.
Perrigo Announces FDA Final Approval For Generic RogaineAllegan-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
FDA: Link Between Food Coloring And Hyperactivity?The Food and Drug Administration wants to know if there could be a link between the artificial food coloring and hyperactivity in children.
Terumo Reaches Agreement With FDA On Quality System ImprovementsTerumo 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.
FDA Warns Of Liver Damage Reports With Sanofi DrugThe Food and Drug Administration said Friday it has received several reports of liver damage with Multaq tablets, including two cases in which patients had to have their livers removed.