Search Result "FDA"


Managing and Responding to FDA Inspections

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 2 Issue: 1 Year: 2015 Page: 33-36
Author(s): Susan Margaret Muhr Leister

Review Article

An Overview of FDA Regulatory Requirements for Vascular Devices

Journal: Applied Drug Research, Clinical Trials and Regulatory Affairs
Volume: 8 Issue: 1 Year: 2021 Page: 53-62
Author(s): Monika Targhotra,Rohan Aggarwal,Meenakshi K. Chauhan

General Review Article

Insights into the FDA 2018 New Drug Approvals

Journal: Current Drug Discovery Technologies
Volume: 18 Issue: 2 Year: 2021 Page: 293-306
Author(s): Alaa Bedair,Fotouh R. Mansour

Review Article

Biosimilars Regulation in the United States and FDA Approved Biosimilars from 2015-2018

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 7 Issue: 1 Year: 2020 Page: 12-29
Author(s): Vikram,Aakash Deep,Manita,Avtar C. Rana,Monu Yadav,Rakesh K. Marwaha

Research Article

An Audit of Black Box Warnings (BBWs) in the United States Food and Drug Administration (US-FDA) Database - A Five-Year Analysis

Journal: Current Drug Safety
Volume: 16 Issue: 0 Year: 2021 Page: 1-5
Author(s): Debdipta Bose,Nithya Gogtay,Tejusv Goel,Mahanjit Konwar

Review Article

Drug Development Process and Novel Drugs Approved by FDA for 2017-18

Journal: Applied Clinical Research, Clinical Trials and Regulatory Affairs
Volume: 5 Issue: 2 Year: 2018 Page: 80-98
Author(s): Aakash Deep,Gaurav Khurana,Aashu Rohilla

Improving the Effect of FDA-Mandated Drug Safety Alerts with Internet- Based Continuing Medical Education

Journal: Current Drug Safety
Volume: 8 Issue: 1 Year: 2013 Page: 11-16
Author(s): Carl N. Kraus, Alan T. Baldwin, R.G. McAllister

Commercially Available, FDA-approved Epigenetic Modifiers As Therapeutic Agents in Bacterial Infection

Journal: Clinical Anti-Inflammatory & Anti-Allergy Drugs (Discontinued)
Volume: 2 Issue: 1 Year: 2015 Page: 79-88
Author(s):

Research Article

In Vitro Screening of an FDA-Approved Library Against ESKAPE Pathogens

Journal: Current Pharmaceutical Design
Volume: 23 Issue: 1 Year: 2017 Page: 2147-2157
Author(s): Waleed Younis,Ahmed AbdelKhalek,Abdelrahman S. Mayhoub,Mohamed N. Seleem

Perspective

2020 FDA Drug-drug Interaction Guidance: A Comparison Analysis and Action Plan by Pharmaceutical Industrial Scientists

Journal: Current Drug Metabolism
Volume: 21 Issue: 6 Year: 2020 Page: 403-426
Author(s): Sirimas Sudsakorn,Praveen Bahadduri,Jennifer Fretland,Chuang Lu

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