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Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows the agencies to share GMP inspection plans and results for API manufacturing sites. Read More
Amid concerns of rising pharmaceutical prices, HHS finalized a rule threatening fines against drugmakers that knowingly overcharge hospitals and providers under the 340B drug discount program. Read More
FDAnews has compiled a list of the 21st Century Cures Act’s requirements and deadlines most relevant to the FDA and the pharmaceutical industry, including upcoming guidances, policies and public reports. Read More
The FDA plans to conduct two studies to gauge whether consumers and healthcare professionals have the capacity to detect and report deception prescription drug advertisements. Read More
The FDA refused to approve Cempra’s community-acquired bacterial pneumonia antibiotic Solithera, citing manufacturing and safety concerns in a complete response letter. Read More