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A Texas-based compounder specializing in hormone therapies for men and women was warned by the FDA for extensive cGMP violations as well as producing drugs for which there was no valid prescription. Read More
The European Commission updated its 2011 action plan against antimicrobial resistance, pledging to boost research into new treatments and develop guidelines for the prudent use of the drugs. Read More
To meet its goals of clearing a backlog of about 200 orphan designation requests before Sept. 21 — and committing to 90-day reviews thereafter — the FDA has formed a “SWAT team” of reviewers dedicated to the task, starting with the oldest applications first. Read More
The FDA cited a Plattsburgh, N.Y., outsourcing facility after an inspection in February and March found serious deficiencies in the company’s cleanliness and sterility practices. Read More
The Department of Veterans Affairs is linking up with the Institute for Clinical and Economic Review to support use of ICER’s drug assessment reports in coverage and price negotiations with the pharmaceutical industry. Read More