Scam, kidnap by South African police

Scam, kidnap by South African police

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Scam, kidnap by South African police

Scam, kidnap by South African police

 
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Regulatory Documentation Certificate 

Part 1: Overview of regulatory agencies and preclinical regulation

FDA
The United States Congress debates and passes laws; institutions set up to make sure laws are followed are regulatory agencies. The agency regulating medicines, medical devices, vaccines, biologics is the Food and Drug Administration, the FDA.

The front page of the FDA website, www.fda.gov, looks beautiful, and logical. Every link works. The problem is that the front page is updated regularly and you will not be able to link to many documents that are stored on their servers. When you find a document from a search engine, or by happening to open it, save it. You may never find it again. The FDA has probably one, or 10, million pages on its site. Maybe more. Who knows? Probably not even them.

The FDA produces videos explaining what it does in general, and specifically. Simply, it takes the laws, from the Federal Register.
Legislation. from FDA.gov Mar 18, 2015

"The Food and Drugs Act of 1906 was the first of more than 200 laws that constitute one of the world's most comprehensive and effective networks of public health and consumer protections. Here are a few of the congressional milestones:
  • The Federal Food, Drug, and Cosmetic Act of 1938 was passed after a legally marketed toxic elixir killed 107 people, including many children. The FD&C Act completely overhauled the public health system. Among other provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.
  • The Kefauver-Harris Amendments of 1962, which were inspired by the thalidomide tragedy in Europe (and the FDA's vigilance that prevented the drug's marketing in the United States), strengthened the rules for drug safety and required manufacturers to prove their drugs' effectiveness.
  • The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices.

Today, the FDA regulates $1 trillion worth of products a year. It ensures the safety of all food except for meat, poultry and some egg products; ensures the safety and effectiveness of all drugs, biological products (including blood, vaccines and tissues for transplantation), medical devices, and animal drugs and feed; and makes sure that cosmetics and medical and consumer products that emit radiation do no harm."
EMEA
The European Medicines Agency is a decentralized agency of the European Union. The Agency, in London, is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.