NDI Guidance Would Weaken Supplement Industry According to Jarrow Formulas

The New Dietary Ingredients (NDI) draft guidance will over-regulate and weaken the supplements industry, according to prominent dietary supplements manufacturer, Jarrow Formulas. The Food and Drug Administration (FDA) first issued the NDI guidance in 2011 in an effort to further define the regulations set in the Dietary Supplement Health and Education Act of 1994 (DSHEA)[…]

Louisiana Drug and Supplement Maker Ordered to Stop Production by Courts

Judge Robert G. James of the District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a producer and distributor of several products including drugs and dietary supplements. The owner, Anton S. Botha, was ordered to cease all business operations until he complies with[…]

DEA: Hemp CBD is a Schedule I Drug

Last week, the Drug Enforcement Agency (DEA) ruled that cannabidiol (CBD) falls within the Schedule I drug classification of the Controlled Substances Act (CSA) and has received an official drug code. Companies have 30-days to update their licenses and cease interstate distribution of CBD and other Cannabis-based extracts. States with laws allowing for CBD and[…]

FDA Releases Unique Device Identifier Draft Guidance

Zachary Brennan of the Regulatory Affairs Professional Society (RAPS) outlined the guidance from the Food and Drug Administration (FDA) about the expected content and forms for the Unique Device Identifier (UDI) for medical device manufacturers and distributors that are coming into effect. UDI Background A UDI is composed of: A device identifier One or more[…]

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Election 2016: The Future of Pharma Under Clinton

Note: This is not an endorsement of Hillary Clinton. InstantGMP™ will be reporting on various aspects of the Presidential candidates’ platforms and their potential impact. By Kelly L. Waters, Marketing Manager (Ms. Waters does not endorse Clinton, she’s just the author) Last week, we profiled Donald Trump’s proposed plan for pharmaceuticals. Now that the Democratic[…]

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Election 2016: The Future of Pharma Under Trump

Note: This is not an endorsement of Donald Trump. InstantGMP™ will be reporting on various aspects of the Presidential candidates’ platforms and their potential impact. By Kelly L. Waters, Marketing Manager (Ms. Waters does not endorse Trump, she’s just the author) Republican Presidential nominee Donald Trump released his proposed health care plan that he would[…]

Turbulence Ahead for Europe’s Pharma Industry Following Brexit

As the votes were being tallied, the entire world had its eye on the UK. The implications of “Brexit” reverberated around the world as it waited with baited breath. In a 52-48 majority, the UK decided to exit the European Union (EU) after close to 50 years. The actual implementation of Brexit will not be[…]

Dr. Rick Soltero Featured in Vape Mentors Masterclass!

Our very own President, Dr. Rick Soltero, had the opportunity to be part of Vape Mentors masterclass talking about the new regulations coming into effect for manufacturers of e-liquids. Be sure to check it out and check out their other online resources! InstantGMP™ Vape and our Standard Operating Procedures for E-Liquids will help your organization[…]

FDA Prioritizing GMP Re-Inspections for High-Risk Dietary Supplement Firms

This article was sparked from reading Josh Long’s post on Insider Law about inspections of Dietary Supplement firms for compliance with Good Manufacturing Practices (GMPs). These firms had previously failed an inspection and were targeted by the FDA as “high-risk”, thus precipitating the need for re-inspection. Josh reports that half of the dietary supplement companies[…]

The FDA Looks to Speed up Medical Device Review

The Food and Drug Administration seeks to speed up the review of medical devices with a new pre-market pilot program. How does the FDA handle pre-market approval now? The FDA uses a group of reviewers from the Office of Device Evaluation (ODE), and the main issue with that is that the pool is populated by[…]