President Trump says drug company executives are coming to see him this week and he expects a major cut in prescription drug prices.
FDA warns Mylan about CGMP deviations in producing active pharmaceutical ingredients at one of its facilities in India.
FDA warns Acella Pharmaceuticals about CGMP and other violations in its production of finished drugs.
Two drug company stakeholders respond to an FDA draft guidance on Orange Book questions and answers.
Attorney Jeffrey Shapiro discusses reasons why HHS made the right decision in ordering FDA to abstain from the premarket review of laboratory-develope...
FDA releases its latest batch of Warning Letters that includes Acella Pharmaceuticals, Mylan and Revival Products.
An assessment finds that combination product review practices are generally efficient and effective and need only minor adjustments.
The Justice Department says the former Indivior global medical director has pleaded guilty to a single misdemeanor charge of introducing misbranded Su...