Rimon

Entries tagged “fda”

6th Medical Communication and Information Summit

events October 25, 2016

Dennis Raglin, life sciences partner at Rimon, P.C. in San Francisco, will be a speaker at the CBI’s “MedComm 2016” conference. He will be discussing best practices for compliance with the FDA’s guidance on the use of social media and participating in a panel discussion on how to effectively respond to requests for off-label information and…

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Supplement Industry Stays On FDA’s Radar with New Draft Guidance for “New Dietary Ingredients” In Supplements

insights September 16, 2016

In this article, posted on Nutraingredients-USA, Dennis Raglin discusses FDA’s new actions against dietary supplements containing ingredients with potential health risks to the public. This action follows the release of an August 11, 2016 revised draft guidance designed to improve the new dietary drug ingredient (NDI) premarket notification process, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” These…

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The FDA Drug Approval Process in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

insights The FDA Drug Approval Process in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success Mark H. Mirkin · February 25, 2014

The U.S. Food & Drug Administration regulates new drug approvals in a process that is extremely thorough, lengthy and expensive. Regulations apply to a drug candidate’s product development phase, the approval process and after approval. Failure to comply could have serious business and financial con-sequences to a biotech venture, including the FDA’s refusal to approve…

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