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FDA Clears Profound Medical Ablation Module

[ Price : $8.95]

FDA clears a Profound Medical 510(k) for the companys Thermal Boost module for use in conjunction with its Tulsa-Pro, which permit...

Exactech Activit-E Polyethylene Cleared

[ Price : $8.95]

FDA clears an Exactech 510(k) for its Activit-E polyethylene for the Vantage Total Ankle System.

VistaPharm Recalls Sucralfate Lot

[ Price : $8.95]

VistaPharm (Largo, FL) recalls one lot of sucralfate oral suspension due to Bacillus cereus contamination.

Coherus Gets Complete Response on Udenyca

[ Price : $8.95]

FDA issues Coherus BioSciences a complete response letter on its BLA supplement for Udenyca Onbody, the companys on-body injector ...

Manufacturing Resumes at Damaged Pfizer Site

[ Price : $8.95]

After suffering severe tornado damage at its Rocky Mount, NC plant, Pfizer says it has now restarted most manufacturing lines.

FDA Releases Novo Nordisk FDA-483

[ Price : $8.95]

FDA releases a two-item Form FDA-483 citing GMP issues documented at Novo Nordisks Clayton, NC facility during a 7/6-13 inspection...

Government, FDA Shutdown Appearing More Likely

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It appears more likely that the federal government, including FDA, will face a 10/1 shutdown due to a Congressional impasse to app...

PDUFA Formal Meetings Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants ...

Guide on Inspection Alternative Tools

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Alternative Tools: Assessing Drug Manufacturing Facilities ...

FDA OKs Jardiance in Chronic Kidney Disease

[ Price : $8.95]

FDA approves Boehringer Ingelheim and Eli Lillys Jardiance (empagliflozin) 10 mg tablets for treating certain patients with chroni...