Related Articles
Agency Alerts
General Regulatory
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May 25, 2017
FDA Approves 1st Drug to Treat Cancer Based on Genetics of Tumor, Not Location
On Tuesday, May 23rd, the FDA granted accelerated approval to Merck & Co.’s Keytruda® (pembrolizumab), a product to treat cancers with a specific genetic feature (also known as a biomarker). ...
FDA
North America
May 20, 2022
FDA Draft Guidance: Risk Management Plans to Mitigate the Potential for Drug Shortages
Industry Draft Guidance Drug shortages pose a significant public health threat as they can delay, and in some cases, even deny critically needed care for patients. Over the past decade, the FDA’s...
Generic Drugs
Agency Alerts
June 24, 2016
CREATES Act: Bipartisan Bill to Help Generic Drug Makers Obtain Samples Needed for Clinical Trials
On Tuesday, June 14, the “Creating and Restoring Equal Access to Equivalent Samples Act of 2016” (CREATES Act) was introduced by members of the Senate Judiciary Committee. This bipartisan bill...