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The FDA hailed a D.C. court’s decision to uphold the agency’s method for assessing if there’s a clinical need for a bulk drug substance as a “victory for public health” and reiterated its focus on oversight of compounders. Read More
Drugmakers, trade groups and medical professionals have reservations about the FDA’s proposed blister pack requirements for certain immediate-release opioids, public comments show. Read More
The FDA is investigating a Novartis subsidiary over “data manipulation” reported only after the agency approved its gene therapy Zolgensma (onasemnogene abeparvovec-xioi). Read More
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