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There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities. Read More
Two FDA advisory committees recommended the FDA approve KemPharm’s opioid pill Apadaz, even though they rejected an abuse-deterrent label for the candidate. Read More
FDA Commissioner Robert Califf made a forceful call for “adequate” funding from Congress to implement pending biomedical innovation legislation. Read More
Sanofi is not bowing out of its efforts to buy Medivation, warning the company’s board that if it continues to brush off its overtures, it will pursue a hostile bid. Read More