222019Jan
News & Views Links

FDA Scott Gottlieb resigned today

3/5/19 | Food and Drug Commissioner Scott Gottlieb, resigned Tuesday, effective in about a month, according to an administration official. READ MORE….

FDA takes steps to improve communications with medical device companies

2/21/19 | “Our mission to provide patients and health care providers with timely access to safe, high-quality medical devices includes conducting prompt, yet thorough, inspections of device manufacturing facilities.” READ MORE….

Medex Cardio-Pulmonary, doing business as Smiths Medical, Recalls Sterile Saline and Sterile Water

2/5/19 | Smiths Medical is recalling the sterile saline and sterile water products for inhalation due to the potential exposure to infectious agents (bacillus infantis and staphylococcus epidermidis) because of damage to the containers used to package the finished products. READ MORE….

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops

1/31/19 | Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen. READ MORE….

Medical Devices and the latest steps to strengthen FDA’s 510(k)

1/22/19 | In 2018, the FDA’s Center for Devices and Radiological Health achieved several new milestones, including a record-setting year for approvals of novel medical devices. READ MORE….