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FDA
Institute of Medicine Report Medical Devices and the Public’s Health: The…
Today, the Institute of Medicine (IOM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process released…
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On Friday of this week, the Institute of Medicine will release their recommendations on the FDA 510K process. The IOM…
US House Energy and Commerce PDUFA Hearing: Transformation of the FDA
Earlier this month, the House of Representatives Energy and Commerce Subcommittee on Health held a hearing on the reauthorization…
Advertising Coalition Responds to FDA Examination of Online…
As we noted earlier this month, the Food and Drug Administration (FDA) published a Notice for Comment regarding the Examination of…
FDA: First Year Report on Bad Ad Program
Last year, the Food and Drug Administration (FDA) launched “The Bad Ad Program,” which is designed to educate health care…
FDA: For Oncologic Medications US Beats Europe on Approval Time
Cancer is arguably the most feared disease, or set of diseases, facing humanity. The symptoms of cancer can be severe and…
FDA Revised Guidance on Oversight of Clinical Investigators’ Financial…
In 1999, the Food and Drug Administration (FDA) began collecting financial disclosure information of clinical investigators. In…
FDA: Examination of Online Direct-to-Consumer Prescription Drug Promotion…
Recently, the Food and Drug Administration (FDA) published a Notice for Comment regarding the Examination of Online…
FDA Conflict of Interest Rules Means Fewer Experts on Advisory Panels
Forty-nine committees, with more than 600 members, advise the Food and Drug Administration (FDA) in their process to approve drugs…
PhRMA Annual Meeting Warns Innovation Requires Regulatory Support
Pharmaceutical industry executives challanged the FDA recently at their annual meeting to improve its regulatory science, clarity…