Topic:

Regulatory

Latest Headlines

Latest Headlines

Missouri Sen. accuses medical equipment companies of wasteful billing

U.S. Sen. Clair McCaskill claims that companies selling diabetic testing, sleep apnea testing and other durable medical equipment are using misleading and possibly fraudulent sales tactics that end up costing Medicare and Medicaid billions of dollars annually.

BD quickly rolling out second drug from new injectables plant

Last month, Becton Dickinson got FDA approval for its antihistamine diphenhydramine hydrochloride injection, the first sterile injectable drug to come out of its new $100 million plant in North Carolina. The second drug to come out of the new plant will be metoclopramide injection, USP, an injectable antiemetic.

Merck nabs 'breakthrough' label for anti-melanoma drug

The designation was based on Phase Ib data that showed significant early signs of antitumor activity in some patients with aggressive cases of the deadly skin cancer.

Merck scores 'breakthrough' status from FDA for immunotherapy against melanoma

Merck ($MRK) has a shot at a speedy development path for lambrolizumab. The FDA has pinned a "Breakthrough Therapy" tag on the experimental antibody drug for advanced melanoma, based on Phase Ib data that showed significant early signs of anti-tumor activity in some patients with aggressive cases of the deadly skin cancer.

J&J's glucose meter recall gets FDA's most serious tag

Last month, Johnson & Johnson voluntarily recalled three models of its market-leading LifeScan glucose meters, and now the FDA has slapped a Class I label on the stateside effort, warning that use of the device could lead to serious injury or death.

U.S. lawmakers take another shot at mandating drug tracking system

The U.S. Senate is headed back into the fray with a bill that would create a national drug tracking system.

CareFusion endures another Class I pump recall

CareFusion was plagued by regulatory problems all last summer, and now the company is reporting an issue with another model of its Alaris infusion pumps, earning the FDA's most-serious warning.

Industry swats EU proposal for U.S.-style device regulation

A European Union proposal to establish a U.S.-style centralized approval process for medical devices is drawing condemnation from a major industry group as a step backward for both patients and the industry.

GSK, Allergan marred by CMO setbacks

Two big-time drugmakers are having to put their plans on hold thanks to problems with contract manufacturers, with GlaxoSmithKline facing a prolonged drug shortage and Allergan enduring an FDA rejection.

Indian clinical trials plunge amid increased scrutiny

India's government is struggling to crack down on loosely regulated clinical trials that have killed hundreds of patients around the country, and while it's unclear if its efforts have made the process safer, they've certainly slowed things down.