Four drug companies respond to an FDA request for input on developing guidance on assessing pH-dependent absorption and potential drug-drug interactio...
Rep. John Sarbanes introduces legislation to require biologic and biosimilar drug manufacturers to report potential pay-for-delay agreements to the Ju...
FDA grants Med-El USA de novo marketing for its Bonebridge bone conduction hearing implant system for individuals 12 years and older who have been dia...
Pharmaceutical Manufacturing Research Services asks FDA not to approve an NDA for Remoxy ER or similar opioid NDAs.
FDA launches a new staff recruitment and retention campaign.
FDA releases its latest batch of Warning Letters that includes one medical product company Lee Silsby Compounding Pharmacy.
FDA approves an AbbVie NDA for Orilissa (elagolix), the first oral gonadotropin-releasing hormone antagonist specifically developed for women with mod...
Federal Register notice: FDA makes available a draft guidance entitled Inborn Errors of Metabolism That Use Dietary Management: Considerations for Opt...