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December 15, 2022

Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims

Docket Number: FDA-2008-D-0150 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist applicants in developing labeling for cardiovascular […]
December 15, 2022

The Plaque Hypothesis: Focus on Vulnerable Lesions to Cut Events The Plaque Hypothesis: Focus on Vulnerable Lesions to Cut Events

A new strategy for the management of atherosclerotic plaque as a source of major adverse cardiac events is needed with the focus shifting from the flow-limiting […]
December 15, 2022

J&J and Merck Ebola Vaccines Produce Lasting Antibodies in Children and Adults: Studies J&J and Merck Ebola Vaccines Produce Lasting Antibodies in Children and Adults: Studies

(Reuters) – Ebola vaccines developed by Johnson & Johnson and Merck & Co produced virus-fighting antibodies and appear to be safe in children and adults, according […]
December 15, 2022

Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (December 2022)

Docket Number: FDA-2013-D-0710 Issued by: Guidance Issuing Office Office of Regulatory Affairs Center for Drug Evaluation and Research Center for Devices and Radiological Health The Food […]
December 15, 2022

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

FDA and European Medicines Agency (EMA) have launched a pilot program to provide parallel scientific advice (PSA) to applicants of abbreviated new drug applications (ANDAs) for […]
December 15, 2022

US Ready to Help China on COVID-19 Surge if Beijing Asks: White House US Ready to Help China on COVID-19 Surge if Beijing Asks: White House

WASHINGTON (Reuters) – The United States is prepared to help China deal with a surge of COVID-19 infections if Beijing requests assistance, the White House said […]
December 15, 2022

Squeezed by Temp Nurse Costs, Hospital Groups Form Staffing Agencies Squeezed by Temp Nurse Costs, Hospital Groups Form Staffing Agencies

Like many nurses these days, Alex Scala got a big pay hike when she switched jobs recently. Scala also received a welcome mix of assignments when […]
December 15, 2022

Beta-thalassemia: Benefits of Gene Therapy Outweigh Costs Beta-thalassemia: Benefits of Gene Therapy Outweigh Costs

Nearly 90% of beta-thalassemia patients were transfusion free for up to 8 years after treatment with the one-time gene therapy betibeglogene autotemcel (beti-cel), according to a report at […]
December 15, 2022

Med Students React: How to Improve Lectures and Rotations Med Students React: How to Improve Lectures and Rotations

Medical students surveyed for a recent Medscape report pleaded with their medical schools to pay greater attention to the quality of lectures during the preclinical years […]
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