The US FDA and Israel

Celebrating U.S. Embassy in Israel

After two decades, a previously unaccomplished move of the United States embassy to Jerusalem from Tel Aviv took place (May 2018). Political guests and world-wide journalists were invited for the elegant official opening and to cover the event.

Successful ME Policies Addressed

The Trump Administration took action and began addressing many Middle East issues that had long gone unattended. The Trump Administration approved and discussed the following policies:

  • recognizing Israel’s jurisdiction of the Golan Heights
  • recognizing Jerusalem as the capital of Israel
  • analysis of American contributions to the United Nations Relief and Works Agency for Palestine Refugees in the Near East
  • the closing of the PLO mission in Washington and many other political issues that have been pending.

Benefits of FDA Office in Israel

Another critical partnership between the U.S. and Israeli officials is the relationship and the procedural contingency cooperation of the U.S. Food and Drug Administration (FDA) and the Israeli Ministry of Health (Misrad Habriut).

An understanding of FDA medical device and drug requirements would help many Israeli businesses save bottom line financials and minimize the risks to their investors both in Israel and around the world.

So far, the American and Israeli cooperation is still on a high. Collaborations between the two nations is a successful collaborative partnership. For medical technologies, the FDA is increasingly visiting Israel to assist in getting Israeli technologies approved for the US market. Understanding FDA requirements makes that mutually beneficial relationship work better.

Like the US, Israel is a leader in creating innovative healthcare products like new medications, cutting edge medical devices, and many nutritional advancements that have successfully impacted the health and wellness of global citizens. Many Israeli global medical device contributions have been in the field of neurology, genetics, cardiology, and much more.

Collaborating Under One Roof

The U.S. FDA also works with global businesses, research universities, scientists, private businesses et al., to develop new and improved medical and food products. The US FDA Israel network is nothing new. Both countries have been working together for years in the field of improved health and regulatory changes, and intellectual property rights with other countries like Latin America, China, India, and throughout Europe.

For example, the following Israeli innovations have been approved by the FDA, or the U.S. and Israel are working together in researching their effectiveness:

  • developing medication to cure migraines
  • create a therapeutic contact lens
  • develop a brain scan reading AI software program
  • approve using MDMA to treat PTSD
  • create a mesh-free product to repair pelvic organ prolapse
  • develop a cure for cancer within the year

Any new medical studies can be worked on together without any long drawn out regulatory exchanges across the seas.

New Discoveries – An Office Move Away

The United States FDA operates under a quality management system in the audit of devices created by manufacturers. These third-party global companies, especially in Israel, will be able to conduct a single review under the U.S. Medical Device Single Audit Program or MDSAP in conjunction with Israel’s Food and Nutrition Services.

By collaborating with the United States FDA to meet requirements within Israeli borders, Israeli companies can take advantage of an excellent opportunity to create a fast expressway for private-sector cooperation between the two countries. Their respective companies in collaboration with each other would help Israeli tech products, and domestic food and drug products to reach the U.S. market a lot quicker and vice versa.

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