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The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and wearable technology and the use of outsourcing and contracting. Read More
In the second day of a two-day meeting, an FDA pediatric cancer advisory panel suggested further international cooperation and emphasized the need for tailoring trials to their specific diseases, while recommending against the use of placebos in pediatric cancer drug trials. Read More
Senate Republicans unveiled their hotly anticipated version of a bill to replace the Affordable Care Act Thursday, which includes the repeal of a pharmaceutical industry tax. Read More
The FDA cautioned manufacturers and consumers that a collection of supplements are illegally marketed drugs containing so-called designer steroids, issuing three warning letters to Flex Fitness/Big Dan’s Fitness, AndroPharm and Hardcore Formulations. Read More
The FDA is changing its labeling requirements for injectable drug products that contain a single active ingredient — swapping ratios of strength with amounts per unit of volume — in an effort to reduce dosage confusion and related adverse outcomes. Read More
An FDA pediatric cancer advisory panel called on multiple sponsors to continue refining their cancer drugs to adapt them for safe and effective use in pediatric populations. Read More