Topic:

Regulatory

Latest Headlines

Latest Headlines

India's Gujarat set to train food and drug inspectors in first state effort

India's Gujarat state government has signed a memorandum of understanding with Underwriters Laboratories to train 60 food-and-drug inspectors to work under the Food and Drug Control Authority.

India's Wockhardt faces mass of lawsuits in U.S. over generic Reglan

Wockhardt's U.S. affiliate must face a mass of suits in a state court over its generic version of the acid reflux drug Reglan (metoclopramide), developed by Wyeth before the firm was bought by Pfizer.

Edwards-backed CardioKinetix reports China heart failure data; U.S. pivotal results expected in 2016

Startup CardioKinetix has reported positive pivotal data from China on its catheter-based heart failure treatment, the Parachute Ventricular Partitioning Device. It expects these study results to support a regulatory submission with the China Food and Drug Administration.

Diagnostics company on verge of $47M settlement with feds over charges of kickbacks to docs

Health Diagnostic Laboratory has reportedly reached a $47 million settlement with the Department of Justice. HDL will deny wrongdoing and enter into a corporate integrity agreement with the Department of Health and Human Services.

Strides gets OK to buy Shasun, expand its manufacturing

With the approval of the Competition Commission of India, Strides Arcolab will pick up Shasun Pharmaceuticals in a $200 million deal that will expand its manufacturing capabilities and cut its costs and, it hopes, its risks.

Abiomed gains after FDA finally approves tiny heart pump

Abiomed has gained full FDA approval of the Impella 2.5 heart pump for use during elective and urgent high-risk percutaneous coronary intervention procedures. The approval is a long time coming after a series of regulatory setbacks forced the company to seek a PMA approval after the indication under a 510(k) clearance proved too narrow.

UPDATED: Nearly 10,000 GE, Siemens MRI machines under FDA recall

Almost 10,000 GE and Siemens MRI machines are being recalled, FDA's database shows. The agency classified the recalls in its second-most severe category, meaning the affected machines "may cause temporary or medically reversible adverse health consequences."

FDA lets Lilly's long-acting Zyprexa off the hook in patient deaths

The FDA says it won't recommend new limits on Eli Lilly schizophrenia med Zyprexa Relprevv after almost a year of investigating the deaths of two patients 3 to 4 days after they received injections.

China FDA approves first proton carbon ion therapy for Siemens device

China's FDA has disclosed its first approval of proton carbon ion therapy equipment by clearing the Siemens device at the Shanghai Heavy Ion Proton Hospital to treat cancer patients with radiation.

South Korea tells Bayer to divest oral contraceptives business

Bayer Korea has been ordered to divest its oral contraceptives business, chiefly its Mercilon (ethinylestradiol) drug, which it acquired when its Germany parent Bayer bought Merck's consumer-care business recently.