Federal Register
2 Guides on Device Performance Based Pathway
Federal Register notice: FDA makes available two draft device-specific guidance documents for the Safety and Performance Based Pathway one on denture...
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 8/27/2021.
Human Drugs
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 8/27/2021.
Human Drugs
Roche Drops Tecentriq Breast Cancer Indication
Roche withdraws its accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy for treating adults with unresectable locally a...
Federal Register
Breckenridges Solifenacin Succinate ANDA Withdrawn
Federal Register notice: FDA withdraws the approval of a Breckenridge Pharmaceutical ANDA for solifenacin succinate tablets (5mg and 10mg) after the c...
Federal Register
CDER Promotional eSubmission Validation Errors
Federal Register notice: CDER announces that 10/18 is the effective date that it will begin rejecting submissions that fail either Electronic Common T...
Medical Devices
Guide on Facet Screw Systems Performance Criteria
FDA posts a draft guidance entitled Facet Screw Systems Performance Criteria for Safety and Performance Based Pathway.
Medical Devices
Guide on Denture Resin Performance Criteria
FDA posts a draft guidance entitled Denture Base Resins Performance Criteria for Safety and Performance Based Pathway.
Medical Devices
Study Confirms Cell Phone Magnetic Interference
A new study by FDA researchers supports an agency recommendation earlier this year that patients keep any consumer electronic devices that may create ...
