In response to complaints about high generic drug user fees, Tanya Dobash erected a parking lot.
The ANDA Repository allows approved abbreviated new drug applications to sit in suspended animation until their owners are ready to...
Inside The ANDA Parking Lot
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A firm will take ownership of US ANDAs from manufacturers unwilling to pay program fees or withdraw the approved generic drug application; is it a novel concept allowing future marketing options or simply fee avoidance?
Learn what's happening at the US FDA. On the go.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
