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The Federal Trade Commission has intervened in a proposed $625 million merger between two leading hydrogen peroxide manufacturers, citing concerns about the deal’s impact on the price of the compound used as an OTC antiseptic and for other purposes. Read More
The U.S. District Court for the District of Columbia has ruled in FDA’s favor in a compounding case, deciding that the agency was right in barring a company from producing and selling a compounded version of vasopressin. Read More
The FDA has released its FY 2020 prescription drug user fees — and sponsors will have to pay considerably more for them compared to last year starting October 1. Read More
Faster development processes have led to some difficulties in completing quality and manufacturing development and data requirements, the meeting report said. Read More
The EMA and FDA have released a report on their workshop to discuss possible solutions to quality and manufacturing challenges drugmakers face when developing medicines under early access programs. Read More
The guidance focuses on identifying critical to quality factors and risk mitigation and emphasizes that patients should be consulted early in the design process. Read More