Who is required to self-identify?
As per the federal law, FDA self-identification is going to start from May 1st, 2019 and the facilities are required to submit their files as soon as possible. Each and every Drug company is requested to update, re-confirm and submit the self-identification form before June 1st, 2019. The manufacturer or any company who plans to become a manufacturer of human generic drug APIs or FDFs are required to self-identify. Any organization or company that package the FDF of human generic drugs into the primary container/closure system will also have to go through this process. Continue reading What You Need To Know About The FDA GDUFA Self Identification Requirements
In the United States, FDA US Agent plays a vital role in regulatory compliance activities. Further, regulatory compliance has a direct impact on your business. It remains the U.S Agent’s responsibility to assist the FDA in communicating with foreign companies when such communication is necessary. U.S Agent should be capable of understanding FDA compliance related matters and effectively communicate with foreign companies. Also, U.S Agent should share any compliance action or FDA communication promptly with foreign companies. Continue reading All You Need To Know Responsibilities Of An FDA US Agent
The Bioterrorism act that was introduced in the year 2002 is meant to check the flow of food and drugs under the Food and Drug Administration (FDA) which is one of the most popular food regulatory agencies in the world. These services were meant to protect the public from food-related emergencies and keep a check on the common issues among the people. Continue reading All You Need To Know About The FDA Food Facility Registration