Medical Devices
Lab Test Firms, Others Plead Guilty in Kickback Scheme
Eleven defendants, including the founders of several lab companies, plead guilty in a $300 million scheme to pay kickbacks to induce medical professio...
Human Drugs
Gileads Veklury OKd for Covid Pediatric Patients
FDA expands the approval of Gilead Sciences Veklury (remdesivir) to include treating Covid-19 pediatric patients 28 days of age and older weighing at ...
Human Drugs
Ardelyx Gets Panel Review on Tenapanor Appeal
CDERs Office of New Drugs says it will convene its Cardiovascular and Renal Drug Advisory Committee to hear an appeal from Ardelyx of a complete respo...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 4/22/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 4/22/2022.
Federal Register
Guide on Nanomaterial in Drugs/Biologics
Federal Register notice: FDA makes available a final guidance entitled Drug Products, Including Biological Products, That Contain Nanomaterials.
Federal Register
Guidance on N-Acetyl-L-Cysteine Policy
Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding N-acetyl-L-cysteine.
Federal Register
Covid-19 Vaccine Guidance Update
Federal Register notice: FDA makes available an updated guidance document entitled Emergency Use Authorization for Vaccines to Prevent Covid19 (Update...
Medical Devices
Guide on 510(k) Refuse to Accept Policy
FDA posts a final guidance entitled Refuse to Accept Policy for 510(k)s that outlines the procedures and criteria the agency intends to use in assessi...
