FDA Related News

Medical Devices

FDA Approves MRI-friendly Labeling for Abbott ICD and Leads

FDA has approved magnetic resonance-conditional labeling for Abbotts Ellipse implantable cardioverter defibrillator and associated pacing leads.

Human Drugs

FDA Complete Response on Janssen Arthritis BLA

FDA issues Janssen Biotech a complete response letter on a BLA for sirukumab and its use in treating moderately to severely active rheumatoid arthriti...

Federal Register

Draft Guide for Biosimilar Analytical Similarity Evaluations

Federal Register notice: FDA makes available a draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity.

Human Drugs

Aegerion Pharma Pleading Guilty to Violating REMS

Aegerion Pharmaceuticals agrees to plead guilty in the Massachusetts federal court to two misdemeanor misbranding charges involving Juxtapid (lomitapi...

5th Circuit Backs Solvay False Claims Case Dismissal

The 5th Circuit Court of Appeals upholds a Texas federal court ruling granting summary judgment to Solvay Pharmaceuticals in a whistleblower False Cla...

Human Drugs

Analytical Similarity Statistical Guidance Out

FDA releases a draft guidance on statistical approaches to evaluating analytical similarity between biosimilars and their reference products.

Human Drugs

Safety Alert Issued on Intercepts Ocaliva

An FDA safety alert warns that Intercept Pharmaceuticals liver disease drug Ocaliva (obeticholic acid) is being incorrectly dosed in some patients wit...

Medical Devices

FDA Clears Brainlab Radiosurgery Planning Software

FDA clears a Brainlab 510(k) for Elements Spine SRS and Elements Cranial SRS, two software applications that aid in the patient-tailored planning of r...

Human Drugs

Public Citizen Sues FDA to Force Benzocaine Ruling

Public Citizen asks the DC federal court to compel FDA to act on the advocacy groups petition asking that benzocaine not be permitted in infant teethi...

Medical Devices

Lawyer Faults New FDA Approach to 510(k)s

Attorney Mark DuVal faults what he sees as FDAs new, less collaborative approach to determining whether a 510(k) is substantially equivalent to its pr...