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The FDA issued a warning letter to Maryland-based Izeen Pharma for significant violations of current good manufacturing practices and misbranding of its thyroid tablets. Read More
The European Medicines Agency released two guidances on medicine shortages for drugmakers and EU regulators — and said the lack of a common definition has meant that the management of shortages in the European Union has been “inconsistent.” Read More
The FDA on Monday announced that it will give priority reviews to ANDAs for opioid overdose treatments to help address the ongoing public health emergency. Read More
Capping the total number of biologic patents that can be litigated at “a reasonable number” would help biosimilar developers enter the market, AAM said. Read More
President Trump announced on Friday that he may issue an executive order to mandate a “favored nations” approach whereby the U.S. will pay no more than the lowest nation’s price for drugs. Read More