US FDA honours woman who rejected thalidomide and saved millions of children's from thalidomide

US FDA honours woman who rejected thalidomide and saved millions of American children's from thalidomide.

Dr Frances Oldham Kelsey a former US FDA employee a medical officer and doctorate in pharmacology from University of Chicago and was honoured by FDA on 13 sep 2010.

As in 1960s as she played a vital role in ensuring that the tragedy drug thalidomide do not get marketing approval in United States of America.

Dr Frances Oldham Kelsey, Now 96 year old lady and a retired US FDA employee refused to approve Kevadon a brand that contained thalidomide  manufactured by pharmaceutical company William S Merrell was restricted to distribute thalidomide in the US after she learnt that the drug is linked with birth defects in Europe.

At that time thalidomide was prescribed to pregnant women for to treat morning sickness and to get good sleep. and, it was not known that thalidomide taken by a mother could affect the foetus.

In the late 1950s and early 60s in Europe thousands of babies were born without limbs, and it was reported later that the birth defects in children’s were developed where ever the mothers of these children’s were prescribed drug thalidomide in pregnancy.

But in US at that time about 40 children’s were born with birth defect as the drug was already distributed through physicians to about 20,000 patients as a part of trial without need for an approval (it was allowed at that time) most of the women took the drug and were not informed about the trial.

Dr Frances Oldham Kelsey was under tremendous pressure from pharma industry for approving the drug , as the drug was already approved in other 20 countries in Europe.

Her decision at that time saved millions of American children’s from the drug thalidomide and the story led the US Congress to set rigid rules for testing and marketing any new drugs in United States of America, which also included a requirement from pharmaceutical companies conduct trials wher the patients participating in clinical trial are well informed and a well informed consent is required by patients participating in clinical trial.

Dr Frances Oldham Kelsey was awarded highest civilian award by then President John F. Kennedy and became the second woman to receive it.

=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.

=====================================================================================================
You may also like following articles

Whar is Referance Listed Drug  ? ( RLD )

What is Pharmaceutical Equivalents

What is Pharmaceutical Alternatives

What is Therapeutic Equivalents


Do Physical properties contribute to drug activity.

What is drug receptor , How a drug resistance occurs

Mechanism of drug resistance

What is drug interaction

Drug interaction, and its examples

What is first pass metabolism of a drug

What is What is 510(k) Clearances ?

What is 510(k) Clearances,

Premarket Notification for medical devices - PMN or 510(k)

What is a drug interaction

Examples of drug interactions


Antibiotic Definition and classification


Antibiotic resitance and Antibiotic resistance mechanism

Antioxidants food suppliments

Vitamin D Details on FDA cautions on accurate dosage of Vitamin D


What is an antibody? what is monoclonal and polyclonal antibodies?

Terminologies In vaccine Production

Multi stage testing of Virus vaccine production

Testing of vaccines at different stages of production

TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION

Enzyme linked immunosorbent assay ELISA

Raido Immuno assay

http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.

http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html

Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in

pharmaceutical industry

Pharmaceutical Validation

Types of validations in pharmaceutical manufacturing

Requirements of documents for validation of sterilisation process

How to investigate OOS out of specification results

Determination of Phenol coefficient of a disinfectant

Sterility testing

Cleen Room Classification

Time limitations in sterile pharmaceuticals processing

Aspects of validation of manufacturing process in sterile pharmaceuticals

Clinical Trials

Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA

How to make Investigational New Drug (IND) Application to US FDA

Drug applications submission to us fda Over the counter Drugs OTC drugs

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Electronic record in pharmaceutical manufacturing industry

Good manufacturing practice in pharmaceutical industry

Pharmaceutical industry pharmaceutical companies and FDA latest updates

Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry

Find a Job in Pharmaceutical Company
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company

1.Quality assurance in pharma industry

2.Quality by designe concept for pharmaceutical industry

3.Quality by designe concept in pharmaceutical industryan explanation