FDA’s Office of Dietary Supplement Programs has responded to a new dietary ingredient notification regarding an ingredient called Oleandrin, the subject of several news stories in the mainstream media and trade press in recent weeks. A biotech company in Texas...
Brand owners working with contract manufacturers must prioritize supply chain transparency in order to meet all the regulatory obligations. This includes brand owners knowing specifications for their product testing, stability and ingredients. Also a contact...
Non-Compliance is the biggest threat to growth of the Pharmaceutical and Nutraceutical industry today. The number of warning letters issued by the Food & Drug Administration (FDA) has increased drastically since 2016. The cost of a single non-compliance event is...
The FDA has issued warning letters on SARMs in dietary supplements. FDA has cautioned products containing Selective Androgen Receptor Modulators (SARMs) are unapproved drugs the agency has not reviewed for safety and effectiveness. Recent warning letters show FDA is...
Products classified as drugs require to disclose all potential side effects to consumers and must get FDA approval before going to the market. Here we briefly go through drugs vs cosmetics. These products are also required to prove their safety and effectiveness. Any...
