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BORANG as 16 D2 FORM as 16 D2 PERMOHONAN KELULUSAN MEMASANG, MENEMPATKAN SEMULAMENGUBAH ALAT KAWALAN PENCEMARAN UDARA PERANGKAP

BORANG as 16 D2 FORM as 16 D2 PERMOHONAN KELULUSAN MEMASANG, MENEMPATKAN SEMULAMENGUBAH ALAT KAWALAN PENCEMARAN UDARA PERANGKAP

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Video instructions and help with filling out and completing BORANG AS 16 D2 FORM AS 16 D2 PERMOHONAN KELULUSAN MEMASANG, MENEMPATKAN SEMULAMENGUBAH ALAT KAWALAN PENCEMARAN UDARA PERANGKAP HABUK EMPAR* DAN CEROBONG DI BAWAH PERATURAN 38, PERATURANPERATURAN KUALITI ALAM SEKELILING UDARA BERSIH,

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Instructions and help about BORANG AS 16 D2 FORM AS 16 D2 PERMOHONAN KELULUSAN MEMASANG, MENEMPATKAN SEMULAMENGUBAH ALAT KAWALAN PENCEMARAN UDARA PERANGKAP HABUK EMPAR* DAN CEROBONG DI BAWAH PERATURAN 38, PERATURANPERATURAN KUALITI ALAM SEKELILING UDARA BERSIH,

good afternoon i'm going to stand as long as i can before my heel is given um so today i'm going to presenting on considerations to be used in determining whether to submit an anda or a 505b2 application and this is based on a guidance that we issued that same name that published in october there are four different routes for the two broad categories of drug applications under the federal food drug and cosmetic act the first is the standalone nda submitted under section 505b1 and approved under section 505c second is the 505b2 nda submitted under 505b2 hence its name and approved under 505c third is the andea submitted and approved under 505j and finally the petitioned and da submitted under 505 j2c and approved under 505j an amda is an application for a duplicate of a previously approved drug product which is the reference listed drug or the rld the amda relies on fda's finding that the rld is safe and effective this application contains information to demonstr

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