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FDA
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…
FDA Staff Disagreements May Be Cause of Delays in Implementation of PDUFA
According to a recent article from the Food and Drug Law Institute (FDLI), the Food and Drug Administration (FDA) in recent years…
FDA Draft Guidance on Safety Labeling Changes
When a pharmaceutical product or medical device is approved by the Food and Drug Administration (FDA), it must be given an…
Senate Special Committee on Aging: FDA and the Reform of the Medical Device…
Continuing the ongoing scrutiny surrounding the regulatory environment for medical devices in America, the Senate Aging Committee …
The Scope of Jurisdiction of DDMAC with Pharmaceutical and Device…
Recently, the Center for Business Intelligence (CBI) held an Evidenced Based Marketing and Promotion conference. One presentation…