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Federal Register

Abdominal Pain Nerve Stimulator is Class 2

Federal Register notice: FDA classifies the nonimplanted nerve stimulator for functional abdominal pain relief into Class 2 (special controls).

Federal Register

Endoscopic Transhepatic Venous Needle is Class 2

Federal Register notice: FDA classifies the endoscopic transhepatic venous access needle into Class 2 (special controls).

Federal Register

FDA Proposes PMAs for Spinal Spheres

Federal Register notice: FDA proposes to require PMAs for spinal spheres for use in intervertebral fusion procedures.

Human Drugs

Biden Bill Will Hurt Generic Drugs: Analysis

A health and science policy analyst for Citizens Against Government Waste says the Build Back Better act proposed by President Biden will hurt the gen...

Human Drugs

Comments on ICH Q13 Continuous Manufacturing Guidance

Three stakeholders submit comments and questions on a draft International Council on Harmonization guidance on continuous manufacturing.

Human Drugs

AbbVie Gains Rinvoq Psoriatic Arthritis Approval

FDA approves AbbVies JAK inhibitor Rinvoq (upadacitinib; 15 mg, once daily) for treating adults with active psoriatic arthritis who have had an inadeq...

Human Drugs

FDA Approves BMS Orencia for Graft Versus Host Disease

FDA approves a new indication for Bristol-Myers Squibbs Orencia to prevent acute graft versus host disease in combination with immunosuppressants.

Human Drugs

FDA Approves Xeljanz for Ankylosing Spondylitis

FDA approves a Pfizer supplemental NDA for its JAK inhibitor Xeljanz /Xeljanz XR (tofacitinib) for treating adults with active ankylosing spondylitis ...

Drug, Device Violations in Dental Technologies Inspection

FDA warns Lincolnwood, IL-based Dental Technologies about CGMP and QS regulation violations at its contract drug and medical device manufacturing faci...

Federal Register

Oncologic Panel to Review Lung Cancer Therapy

Federal Register notice: FDA announces a 2/10/2022 Oncologic Drugs Advisory Committee meeting that will vote on an Innovent Biologics BLA for sintilim...