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The FDA is giving a gentle but clear nudge to industry on stem cells with a new rapid-response program to help regenerative medicine makers to get on the right side of the law. Read More
The FDA’s ad police warned a Campbell, Calif.-based company to stop claiming that its prescription diet pill can help patients lose weight three times faster than diet and exercise alone. Read More
As part of its ongoing enforcement efforts against drug compounders, the FDA plans to move the program’s base of operations from CDER’s Office of the Center Director to the Office of Compliance, Director Janet Woodcock announced. Read More
The House Appropriations committee approved nearly $3.3 billion in spending for the FDA for fiscal year 2020 and once again nudged the agency to get going on its delayed continuous manufacturing initiative. Read More
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