Question

Drug ANC has been found to be ineffective in the market 3 months after its launch? What are the remedial outcomes available to FDA and EMA?

Answer 1

FDA and EMA are the regulatory bodies which carry out the all the regulations of drug and its safety. the abbrevations are

FDA

Food and Drug Administration. FDA is federal agency of United Nation which regulates all activities related to drug safety and food like recognition, testings, qualitative analysis etc.

EMA

The European Medicines Agency. EMA is an agency of the European Union which regulates the evaluation and supervision of medicinal products.

If any drug is found to be ineffective these organizations will take measures such as

1) The drug will be withdrawn from markets

2) The licence for the production of those drugs will be made void.

3) The company might lose the licence or have to face the ban for a period of time.

4) The other drugs produced by the company will be kept withheld.

5) Informations will be given to public for not using the drug.

6) If any person claim to be affected with the inverse effect, the company is liable for the payment of compensation.

7) Once a medicine is recalled FDA will demand the firm to provide product related information.

8) Evaluation of risk associated with the deficiency or the poosible defifiencies it might cause in the future.

9) Reason for removal of drug and the possible risk associated with it.

10) The total amount of prducts produced and the time span of the products.

11) The total amount of such product distributed will be evaluated.

12) The company needs to provide the distribution information along with the contact information of the firm official who is the point of contact concerning the recall to these regulatory bodies.

13) The company should release a recall letter notifyng each of the distributers of the market.

14) The company needto provide the recall status to the organizations.