Regulatory/Legislative News

The U.S. Food and Drug Administration approved an investigational new drug application from Allegro Ophthalmics to begin two phase 2 studies of an integrin peptide therapy for patients with wet age-related macular degeneration or symptomatic vitreomacular traction, according to a news release.

In the 7 years since its creation, the Medicare Fraud Strike Force (MFSF) has indicted more than 1,500 individuals for Medicare fraud. Based on Department of Justice (DOJ) statistics, those 1,500 people collectively billed the Medicare program for more than $5 billion. While these numbers seem large, they hide the real and inherent value of the work being done in the nine MFSF cities across the country.

The United Kingdom’s National Institute for Health and Care Excellence, or NICE, has issued a final appraisal determination calling for funding of Iluvien for the treatment of pseudophakic eyes in patients with chronic diabetic macular edema considered insufficiently responsive to available therapies, according to a news release.

The European Parliament’s Committee for Environment, Public Health and Food Safety recently voted for a scrutiny procedure in combination with a de facto case-by-case premarketing centralized authorization system in Europe.

Last week, I had the unique opportunity to present before the FDA Ophthalmic Devices Panel the clinical results and experience with the ReSure ocular sealant proposed for approval for sealing leaking cataract wounds. 

FDA has announced its final rule for a unique device identification system that will help to locate medical devices and improve patient safety as well as assist the FDA in identifying problems and issue targeted recalls.

Aerie Pharmaceuticals has filed an S-1 registration statement with the U.S. Securities and Exchange Commission involving a proposed initial public offering of common stock, according to a company news release.

GAITHERSBURG, Md. — The Ophthalmic Devices Panel of the U.S. Food and Drug Administration voted to recommend approval of ReSure Sealant.

Leiter’s Compounding Pharmacy has voluntarily issued a nationwide recall of three lots of sterile products due to concerns regarding its independent testing lab, Front Range Laboratories, according to a release from the U.S. Food and Drug Administration.

In a recent decision (Township Pharmacy v. Division of Medical Assistance and Health Services), a New Jersey appellate court upheld the denial of a pharmacy owner’s application to participate in the New Jersey Medicaid program as a pharmaceutical service provider because he failed to disclose an employee’s criminal past on his application.