FDA Review posts the Federal Register notices for the week ending 11/29/2019.
Federal Register notice: FDA debars Tzvi Lexier for 10 years from importing any drug into the U.S. because he was convicted for conspiracy to smuggle ...
FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed.
Federal Register notice: FDA makes available a draft guidance entitled Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insul...
FDA approves a Qiagen and DiaSorin PMA for the automated workflow for QuantiFeron-TB Plus, a fourth-generation test for latent tuberculosis detection.
FDA clears a Zebra Medical Vision 510(k) for its HealthCXR device intended for use in identifying and triaging pleural effusion in Chest X-rays.
FDA says B. Braun is recalling 43,026 blood administration sets that may leak at the joint between blood filters and tubing.