How to Speed Up Phase IV Clinical Trials

Post-marketing research (Phase IV trials) is necessary for many products; however, many life sciences companies are falling behind in completing their Phase IV trials on time. What can they do? To remedy this, many companies are allowing their medical affairs...

New Risks for FDA Warning Letters

Generally, when manufacturers of drugs and medical devices receive a warning letter from the FDA, they plead innocence, follow the FDA’s instructions to right their wrongs, and that’s that. Now, however, governmental entities in litigation against these...