Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 9/24/2021.
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 for the week ending 9/24/2021.
Human Drugs
FDA Extends Review of Pfizer Growth Hormone
FDA extends by three months the review of a Pfizer/Opko Health BLA for somatrogon, a once-weekly long-acting recombinant human growth hormone for trea...
Medical Devices
Armstrong Medical Recalls Anesthesia Gas Cans
Armstrong Medical recalls its Amsorb Plus Prefilled G-Can 1.0L due to reports that some canisters have difficulties with gas flow that may cause a red...
Federal Register
Sunscreen OTC Monograph Proposed Order Available
Federal Register notice: FDA makes availability of an over-the-counter monograph proposed order entitled Amending Over-the-Counter (OTC) Monograph M02...
Federal Register
FDA Revokes 3 EUAs for No-longer-marketed Tests
Federal Register notice: FDA revokes the emergency use authorizations for three Covid-19 tests after the companies requested such because the tests ar...
Human Drugs
FDA Generic Drugs Office Modifies Scientific Priorities
The CDER Office of Generic Drugs revises its scientific priorities as part of its user fee performance goals through 2022.
Biologics
FDA Approves Expanded Repatha Use
FDA approves an Amgen supplemental BLA for Repatha (evolocumab) injection as an add-on treatment to diet alone or together with certain other therapie...
Human Drugs
FDA Approves Tivdak for Cervical Cancer
FDA grants Genmab and Seagen accelerated approval for their BLA for Tivdak (tisotumab vedotin-tftv), an antibody-drug conjugate for treating certain a...
