Tag: FDA

Additional Transparency for Clinical Trials Announced by Industry Groups

On July 24, 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced joint endorsement of the “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.”  These principles applicable to biopharmaceutical companies take effect January 1, […]

LITIGATION ROUND-UP

Settlements The U.S. Department of Justice (DOJ) announced on July 18, 2013 that pharmaceutical manufacturer Mallinckrodt LLC agreed to pay $3.5 million to settle a civil False Claims Act suit. The complaint alleged that Mallinckrodt paid illegal kickbacks to health care professionals in the form of speaker honoraria, clinical trials funding, and honoraria […]

FDA Continues Enforcement Against Internet Marketing of Unapproved and Misbranded Drugs

EvaPharmacy recently received a Warning Letter from the United States Food and Drug Administration (“FDA”), Office of Drug Security, Integrity and Recalls regarding products available for sale to consumers in the United States on its websites.  The FDA requested that EvaPharmacy take prompt action and notify the FDA within ten […]

Regulatory Uncertainty as FDA Draft Guidance on Mobile Medical Applications Reaches its Two-Year Anniversary

Many see great promise for patients and physicians utilizing mobile devices in health care. Growth of so-called “mhealth” has been fueled by faster, more ubiquitous technology, decreasing costs, and more user-friendly applications. However, regulatory uncertainty remains a barrier to the adoption of mobile health technology.  Two years following the FDA’s […]

FDA Issues Draft Guidance on Reporting Adverse Events for Medical Device Manufacturers

The Food and Drug Administration Center for Devices and Radiological Health released draft guidance on July 9, 2013 titled, Medical Device Reporting for Manufacturers.  Written comments may be submitted by mail or electronically to the FDA within 90 days.  When finalized, the guidance will supercede the 1997 guidance document with the […]