Wockhardt is in hot water with the FDA again, receiving another warning letter for significant GMP violations regarding quality and data controls. Source: International Pharmaceutical Regulatory Monitor
The FDA plans to require risk evaluation and mitigation strategies for opioid analgesics — including immediate, extended-release and long-acting formulations — to ensure the benefits outweigh the risks of misuse,…
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Source: International Pharmaceutical Regulatory Monitor
The Justice Department recovered $4.7 billion in False Claims Act settlements, with the largest recoveries coming from the life sciences industry at $1.2 billion in the last fiscal year. Source:…
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 First Amendment does not preclude drugmakers from FDA’s oversight of off-label communication even if what they say is truthful. Source: Drug Industry Daily
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