Scribd
Upload
27 views

ADVERSE REACTION: (Adverse Event) : Also Known As Side Effects, Adverse

Adverse reactions refer to any undesired side effects that may occur from an experimental drug or treatment, which must be evaluated for both immediate and long-term effects. For a drug, device, or biologic to be marketed, it must go through a regulatory approval process including animal and clinical testing for safety and efficacy, followed by the manufacturer filing an application that is then reviewed and approved or rejected by the country's regulatory agency.

Uploaded by

munny000
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
27 views

ADVERSE REACTION: (Adverse Event) : Also Known As Side Effects, Adverse

Adverse reactions refer to any undesired side effects that may occur from an experimental drug or treatment, which must be evaluated for both immediate and long-term effects. For a drug, device, or biologic to be marketed, it must go through a regulatory approval process including animal and clinical testing for safety and efficacy, followed by the manufacturer filing an application that is then reviewed and approved or rejected by the country's regulatory agency.

Uploaded by

munny000
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 1

ADVERSE REACTION: (Adverse Event): Also known as side effects, adverse

reactions include any undesired actions or effects of the experimental drug or treatment.
Experimental treatments must be evaluated for both immediate and long-term side
effects.
APPROVAL: A drug, device or biologic must be approved by a country’s regulatory
agency before it can be marketed. The approval process involves several steps
including pre-clinical (animal) studies, clinical trials for safety and efficacy, filing of a New
Drug Application (NDA) in the United States or Marketing Authorization Application
(MAA) in Europe by the manufacturer, regulatory agency review of the application, and
agency approval/rejection of application.

You might also like