Define: Tentative Approval

How is Tentative Approval defined in a legal contract?

• Tentative Approval means the conclusion that a drug product has met all required safety, efficacy, and quality standards. However, due to existing patent protections, it is not yet ready to be marketed. Despite this, being tentatively approved makes the product eligible for consideration beyond the United States borders.
  Seen in 18 SEC Filings.
• Tentative Approval means a drug product has been deemed by the FDA to be safe, effective, and equivalent to its brand name counterpart. Despite meeting all these standards, existing legal or regulatory barriers, such as individual drug exclusivity, prevent the FDA from providing final approval.
  Seen in 2 SEC Filings.

Please note: The above definitions do not pertain to specific agencies, companies, associations, individuals, or locations. They have been rendered in a simplified and generalized form that retains their core meaning, making them accessible and understandable to the average business user.

Note: The Genie AI Legal Assistant pulled this data out of the SEC EDGAR Database of 500,000 records from the past 22 years of filings. We regularly update this page as new filings and definitions come in.

Search EDGAR for ‘Definitions of tentative approval’ yourself to verify these results. We are always keen to point people to source documents.

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Which definition should you use?

🤔 Our AI Legal Assistant has combined and improved the above descriptions to create market-standard 'Genie definitions' below, with guidance on which documents and which industry to use for each.

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Genie Definition 1

• Tentative Approval means a drug product fulfills necessary safety, efficacy, and quality standards, but cannot be marketed due to patent protections. It remains eligible for international consideration.

Relevant Contract Types

• Intellectual Property Licensing Agreement
• Research and Development Agreement
• Joint Venture Agreement
• Product Supply Agreement

Relevant Circumstances

• Drug development and marketing processes.
• Purposing a product for international outreach.

Relevant Sectors

• Pharmaceuticals Sector
• Biotechnology Sector
• Healthcare Sector

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