Author: masuuglobal

US FDA Temporary Policies for Compounding Certain Parenteral Drug Products Guidance for Industry: As of October 10, 2024, under section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)), HHS Secretary Becerra has declared public health emergencies (PHEs) in North Carolina, Florida, Georgia, Tennessee, and South Carolina due to the impacts of Hurricane Helene,… Continue reading US FDA Temporary Policies for Compounding Certain Parenteral Drug Products Guidance for Industry

The regulation of dietary supplements by the FDA under the Dietary Supplement Health and Education Act of 1994 (DSHEA) emphasizes the responsibility of manufacturers and distributors to ensure their products are safe and accurately labelled. Here are some key points regarding recent updates and resources related to dietary supplements:

The FDA oversees both finished dietary supplement products and dietary components. The FDA regulates dietary supplements differently than it does “conventional” foods and drugs. According to the Dietary Supplement Health and Education Act of 1994 (DSHEA):

Nitrosamine impurities guidance updated with more information related to root causes of formation, mitigation and implementation of recommended AI limits and setting of specification for the recommended acceptable intake in drug products. Guidance has updated from February 2021 Revision 1 to September 2024 Revision 2 complete details provided below:

This updated guidance outlines how the assessment goals established by the Generic Drug User Fee Amendments of 2022 (GDUFA III) apply to amendments made to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) submitted to the FDA. It also provides detailed information on the classification of amendments and how these classifications can impact… Continue reading FDA revised guidance for industry titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.”