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The House Energy & Commerce Committee is calling on the GAO to evaluate whether the FDA’s regulatory pathway for generic versions of complex drugs is sufficient. Read More
In what may be a first, the FDA has settled an industry suit accusing the agency of overstepping its regulatory authority over pharmaceutical promotion. Read More
India’s Natco Pharma and partner Alvogen announced Monday that they have settled a patent infringement suit filed by Gilead Sciences, Roche and Genentech over a proposed generic version of Tamiflu. Read More
With the clock about to strike midnight on 2015, CDER Director Janet Woodcock laid out a set of priorities the center will focus on in 2016, with negotiating new PDUFA and GDUFA agreements topping that list. Read More
Health Canada has agreed to comply with a Canadian court ruling quashing the agency’s import ban on drugs from a generics manufacturer. In a Nov. 2 statement, Health Canada retracted an update that prohibited imports from two Apotex facilities in India. Read More
The Italian Medicines Agency has issued a noncompliance statement to Rome-based radiopharmaceutical maker Iason Italia, hitting the company over deficiencies primarily related to sterility assurance. Read More
An international aid group has negotiated a multi-year licensing agreement with Bristol-Myers Squibb to produce generic hepatitis C medicines in many developing nations. Read More