FDA releases the FDA-483 with six observations from a 2016 inspection at the Mylan finished drug manufacturing facility in Maharashta, India.
FDA releases an updated list of medication guides with three new and 22 updated guides.
FDA releases its latest batch of Warning Letters that includes one medical product company Henan Lihua Pharmaceutical Co.
FDA commissioner Scott Gottlieb says FDA will help drug innovators by publishing a list of surrogate endpoints used to approve or clear drugs or biolo...
ProPublica explores the possibility that)user fees and industry support of doctors have led to FDA becoming more of an industry partner than a regulat...
CBER creates a new dialog avenue for biologic product developers to ask agency experts for advice on advancing a potential product.
Federal Register notice: FDA submits for OMB approval an information collection revision entitled Guidance for Industry: Assessing User Fees Under the...
FDA approves a GW Research NDA for Epidiolex (cannabidiol) oral solution for treating seizures associated with two rare and severe forms of epilepsy, ...