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September 15, 2022

‘A Gut Check:’ Do Tumor Boards Improve Care? ‘A Gut Check:’ Do Tumor Boards Improve Care?

When oncologists and other clinicians come together to discuss a challenging cancer case, the hope is the patient will do better. But that’s not necessarily a […]
September 15, 2022

Extravascular ICD Surpasses Goals in Pivotal Trial Extravascular ICD Surpasses Goals in Pivotal Trial

BARCELONA – A novel “extravascular” implantable cardioverter defibrillator (ICD) that uses substernally placed electrodes surpassed its prespecified efficacy and safety targets in the device’s pivotal trial […]
September 15, 2022

Questions and Answers on Current Good Manufacturing Practice Requirements | Buildings and Facilities

What is penicillin? What are the penicillin drugs? Is cross-contamination a concern with penicillin drugs? Are there special manufacturing requirements for penicillin drugs? Why is FDA […]
September 15, 2022

Instructions for Completing Form FDA 3500

B1:      Type of ReportB2:      Outcome Attributed to Adverse EventB3:      Date of EventB4:      Date of this ReportB5:     […]
September 15, 2022

Questions and Answers on Current Good Manufacturing Practice Questions and Answers on Current Good Manufacturing Practice Requirements | General Provisions

Docket Number: FDA-2017-D-6821 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Home | General Provisions | Buildings and Facilities | Equipment | Control […]
September 15, 2022

Q&A on CGMP Requirements

As part of the Current Good Manufacturing Practices (CGMP) initiative announced in August of 2002, and to help FDA be more transparent with CGMP policy, we […]
September 15, 2022

MedWatch Forms for FDA Safety Reporting

Voluntary Reporting For use by Health Professionals, Consumers, and Patients Reporting can be done through our online reporting portal or by downloading, completing and then submitting […]
September 15, 2022

How Do You Feel About Wearable Medical Devices? How Do You Feel About Wearable Medical Devices?

Technology has helped develop personal devices that can monitor numerous aspects of one’s health outside of your doctor’s office. Many physicians are taking advantage of data […]
September 15, 2022

Court Ruling May Bring Back Copays for Preventive Services Court Ruling May Bring Back Copays for Preventive Services

Tom and Mary Jo York are a health-conscious couple, going in for annual physicals and periodic colorectal cancer screening tests. Mary Jo, whose mother and aunts […]
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