Regulatory/Status Index
This index characterizes the regulatory and marketing status and other aspects of products in
BIOPHARMA: Biopharmaceutical Products in the U.S. and European Markets.
This is a static, unedited list from the database, Nov. 2009. It is always best to search the database.
If you had a database subscription, the list below would include the entries for each term with database links to product monographs.
- 505(b)(2) generic drug approvals 165 -->
- accelerated approval (based on surrogate endpoints) (FDAapproved)
- application expected (2007-8) in U.S.
- application expected (2007/8) in Europe (EU or European countries)
- application pending, EU or European countries
- application rejected, EU
- application withdrawn in EU
- approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
- approval pending, U.S.
- approval rejected in U.S.
- approvals , FDA, as biologic
- approvals , FDA, as biologic
- approvals , FDA, as biologic
- approvals, Mexico
- approvals , U.S, as drugs
- approvals, U.S., as drugs
- approvals, U.S., as medical devices
- approved in U.S.
- approved, EU or European countries, but not actively marketed
- approved, formerly in U.S. (approval withdrawn)
- approved, formerly, in EU or European countries
- approved, U.S.
- biodefense stockpile (U.S.)
- biodefense stockpile, European countries
- biogenerics, biosimilars, biocomparables, follow-on proteins, etc. (approval based on abbbreviated/comparative filing)
- bovine source warning, BSE country
- bovine source warning, unknown/undocumented country
- CBER to CDER transfers
- Collaborative R&D Agreements (CRADA)
- Continuous Marketing Application (CMA) Pilot 2 Program
- controlled/govโt distribution in European counties
- controlled/govโt distribution in U.S.
- Drug Efficacy Study Implementation (DESI)
- exempt from CBER lot release requirements
- expanded access/compassionate use
- FDA application denied
- FDA application withdrawn
- Good Manufacturing Practices (GMP) violations
- IND, available through
- murine source materials
- not available in U.S., currently (not marketed; includes intermediates, components, etc.)
- not available, currently, in EU or European countries (not marketed)
- orphan status
- orphan status
- orphan status (EU)
- patent extended (under 35 USC ยง156)
- priority review
- priority review status
- risk evaluation and mitigation strategy (REMS)
- Special Protocol Assessment (SPA)
- Treatment IND