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August 25, 2022

NSAIDs Linked to Heart Failure Risk in Diabetes NSAIDs Linked to Heart Failure Risk in Diabetes

People with diabetes who take nonsteroidal anti-inflammatory drugs even on a short-term basis may have about a 50% greater risk of developing heart failure, according to […]
August 25, 2022

Study Data Standards Update for CBER: Your Guide to a Successful Submission – 10/05/2022

On This Page Date: October 5, 2022 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR CBER […]
August 25, 2022

Congressman’s Wife Died After Taking Weight Loss Remedy Congressman’s Wife Died After Taking Weight Loss Remedy

SACRAMENTO, Calif. — The wife of a Northern California congressman died late last year after ingesting a plant that is generally considered safe and is used […]
August 25, 2022

Medtronic Recalls Additional Faulty HeartWare HVAD Batteries Medtronic Recalls Additional Faulty HeartWare HVAD Batteries

Medtronic is recalling 23,372 HeartWare HVAD System batteries due to the risk that they could unexpectedly fail, the US Food and Drug Administration (FDA) says in […]
August 25, 2022

Gender Dysphoria Covered by Disability Law, Court Rules Gender Dysphoria Covered by Disability Law, Court Rules

RICHMOND, Va. (AP) — A federal ruling that gender dysphoria is covered by the Americans with Disabilities Act could help block conservative political efforts to restrict […]
August 25, 2022

Fewer Retained Surgical Items With RF Chips and TeamSTEPPS Fewer Retained Surgical Items With RF Chips and TeamSTEPPS

Surgical teams who use radiofrequency (RF) identification chips and the TeamStepps protocol dramatically decrease the chance of accidentally leaving surgical items in the patient’s body, a […]
August 25, 2022

Problems With Drugs That Get Speedy OKs: What To Do? Problems With Drugs That Get Speedy OKs: What To Do?

Many of the drugs that have been granted accelerated approvals do not have marked  advantages to existing therapies, and further testing of these drugs to confirm […]
August 25, 2022

Office of Generic Drugs | Offices and Divisions

Immediate Office (IO) Sally Choe, Ph.D., Director, Office of Generic Drugs (OGD) Kendra Stewart, R.Ph., Pharm.D., (Acting) Deputy Director of Operations Iilun C. Murphy, M.D., Deputy […]
August 25, 2022

FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement – 11/14/2022

On This Page Date: November 14 – 16, 2022 Day1: Mon, Nov 14 10:00 AM – 3:00 PM ET Day2: Tue, Nov 15 10:00 AM – […]
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