Product Liability Update

Adopting a Safety Policy and Assembling a Safety Team

Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand, loss of consumer confidence, harm to the business and trigger potential regulatory consequences as well as result in […]

| 6 min read
DW

FDA Issues Draft Guidance on Distributing New Risk Information for Approved Drugs and Biologics

In June 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance for the distribution of new risk information for approved prescription drugs to healthcare professionals and healthcare entities. The draft guidance, entitled Guidance for Industry Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices, establishes […]

| 4 min read
DW

FDA Issues New Draft Guidance on Medical Device Data Systems

On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance advising that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices and medical image communications devices, due to the low risk they pose to patients. The guidance, titled […]

| 3 min read
DW

Summary of FDA Guidance on Mobile Medical Apps

Overview On September 25, 2013, the FDA issued its final guidance explaining how it plans to regulate mobile medical applications, or “apps,” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance clarifies which mobile apps[1] will be regulated by the FDA and who will be required to comply with the regulations. The […]

| 8 min read
DW