Human Drugs
FDA Rejects Lipocine NDA for Testosterone Drug
FDA issues Lipocine a complete response letter on its NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in a...
Human Drugs
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 11/8/2019.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Aurobindo Recalls Ranitidine Products
FDA says Aurobindo has recalled 38 lots of ranitidine products for unacceptable NDMA levels.
Human Drugs
FDA Approves Celgenes Reblozyl for Some Anemic Adults
FDA approves Celgenes Reblozyl as the first treatment for adults with anemia who have beta thalassemia and require regular red blood cell transfusions...
Human Drugs
Cassiopea NDA Filed for New Acne Cream
FDA accepts for review a Cassiopea NDA for clascoterone cream 1% for treating acne.
FDA General
E-cigarette Rule Coming: Trump
President Trump says new e-cigarette rules will be out within a week, including raising the purchasing age from 18 to 21.
Medical Devices
Teleflex Class 1 Recall of Ventilator Manifold
Teleflex begins a Class 1 recall of its Babi.Plus 12.5 cm H2O Pressure Relief Manifold, which is used with its ventilators, because the devices vented...
Medical Devices
Life Spine, 2 Execs, Settle Kickback Case
Life Spine and two of its executives agree to pay nearly $6 million to resolve kickback allegations in a whistleblower suit.
Medical Devices
Changes in Special 510(k) Guidance
CDRH regulatory advisor Joshua Silverstein tells a Webinar what changes were made to the final Special 510(k) guidance in response to comments on the ...
