The U.S. Food and Drug Administration (FDA) has several pilot programs underway that should make many medical device applications simpler and faster. For premarket notifications, the 510(k) eSubmissions Program will guide companies in putting together and submitting a 510(k) application -- resulting... Read More
On August 1, 2014, the U.S. Food and Drug Administration (FDA) announced the fiscal year 2015 user fees for pharmaceutical and medical device companies. These rates will be effective from October 1, 2014 through September 30, 2015. For medical devices, a premarket... Read More
In late June 2014, the FDA released a draft guidance entitled Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. The guidance announced that these types of systems and devices would no longer need to comply with some... Read More
In January 2013, FDA inspectors made public a warning letter issued to a Taiwanese chemical manufacturer in December. Citing serious violations of recordkeeping and in-process testing, the letter said that Beanne Chemical facility had failed on multiple counts to validate its manufacturing... Read More
The Asia-Pacific Economic Cooperation (APEC) group recently declared a goal to align regulatory processes for medical devices and pharmaceutical products by 2020. APEC consists of 21 countries, including the US, China, Australia, and South Korea. The initiative is called the “Strategic Framework... Read More
The US-South Korean Free Trade Agreement (KORUS FTA) is expected to improve the competitiveness of US medical equipment and pharmaceuticals. Once approved by the US Congress, the KORUS FTA will enable more than 90% of US medical equipment exported to South Korea... Read More
President Obama has declared his intentions to move forward with the Korea – U.S. Free Trade Agreement (KORUS). Written three years ago under President Bush, it includes provisions on the pharmaceutical and medical devices markets. Korean parliament has already passed the deal,... Read More
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) recently reached an agreement with the U.S. Pharmacopeia (USP) in February 2010 and consequently has sent out one of its executive employees as a liaison officer to the USP. This liaison officer will be responsible... Read More
Japan 's Ministry of Health, Labor, and Welfare (MHLW) with the Pharmaceuticals and Medical Devices Agency (PMDA) concluded confidentiality agreements with the European Commission's Directorate General Enterprise and Industry and Health Canada. Both these agreements were signed in October 2009. The United... Read More
The United States and Japan issued a report detailing the progress of the US-Japan Regulatory Reform and Competition Policy Initiative. The Initiative was established to encourage fairer competition, improve the business environment in Japan, and promote bilateral economic growth through regulatory reform.... Read More