FDA Related News

Medical Devices

FDA Clears Gold Standard Diagnostics Lyme Assay

FDA clears a Gold Standard Diagnostics 510(k) for its Borrelia burgdorferi IgG/IgM ELISA Lyme assay.

Human Drugs

Generic Drug Industry Challenges Aired

FDA and generic drug industry representatives shared insights on threats to the industry and elements of the GDUFA 2 commitment letter during an imple...

Medical Devices

Least Burdensome Mandatory Training Held

FDA reports to Congress on its activities to implement a Cures Act requirement for mandatory staff training on medical device least burdensome princip...

Human Drugs

Appeals Court Backs Lipitor Case Dismissal

The 4th Circuit Court of Appeals upholds a lower court decision dismissing multi-state litigation alleging that patients contracted diabetes after tak...

Human Drugs

Orphan Status for Chiesi Cell Therapy for Eye Condition

FDA grants Chiesi USA an orphan drug designation for GPLSCD01, ex-vivo expanded autologous human corneal epithelial cells containing stem cells, for t...

Medical Devices

Safety Update on Certain Heater-Cooler Devices

FDA issues a safety update on LivaNovas Stӧckert 3T Heater-Cooler System to help prevent the spread of infection related to the use of the devic...

2 Updated Medical Product Communications Guidances

FDA finalizes two guidances with recommendations on industry communications with payors and other entities.

Human Drugs

Lilly, AstraZeneca Scrap Phase 3 Alzheimers Studies

Based on disappointing data, Eli Lilly and AstraZeneca are discontinue global Phase 3 clinical trials of lanabecestat for treating Alzheimers disease....

Human Drugs

Taiwan Biotech CGMP Violations

FDA warns Taiwans Taiwan Biotech about CGMP violations in its production of finished drugs.

Heart Trial Protocol Changed: Public Citizen

Public Citizen says HHS has made changes to an NIH cardiac trial protocol and consent form to ease ethical concerns raised by the advocacy group.