FDA releases its latest batch of Warning Letters that includes Advanced Botanical Consulting and Testing, Spectrum Laboratory Products and Vida Intern...
FDA Review posts product approval summaries for the week ending 6/14/2019.
FDA revises its guidance on ANDA Submissions Content and Format.
Patients and consumers worried about dental amalgams mercury content and its risks flood an FDA docket seeking input on Patient Preference Information...
Federal Register notice: FDA makes available a draft guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices.
Merck, Eli Lilly and Amgen sue HHS to block a rule that would require drug prices be included in direct-to-consumer ads.
Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified the agency that the drug products were no lon...
Federal Register notice: FDA requests that any consumer organizations interested in participating in selecting voting or nonvoting consumer representa...