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1 3 0F o o d a n d D r u g A d m i n i s t r a t i o n , C e n t e r f o r D r u g E v a l u a t i o n a n d R e s e a r c h ( C D E R ) , O f f i c e o f P h a r m a c e u t i c a l Q u a l i t y . M a n u a l o f P o l i c i e s a n d P r o c e d u r e s ( M A P P ) , P o l i c y a n d P r o c e d u r e s , 5 0 4 0 . 1 , P r o d u c t Q u a l i t y M i c r o b i o l o g y I n f o r m a t i o n i n t h e C o m m o n T e c h n i c a l D o c u m e n t - Q u a l i t y ( C T D - Q ) . J a n u a r y 2 0 1 7
1 4 0F o o d a n d D r u g A d m i n i s t r a t i o n , C e n t e r f o r D r u g E v a l u a t i o n a n d R e s e a r c h ( C D E R ) . G u i d a n c e f o r I n d u s t r y : A N D A S u b m i s s i o n s R e f u s e - t o - R e c e i v e S t a n d a r d s . D e c e m b e r , 2 0 1 6
1 5 0F o o d a n d D r u g A d m i n i s t r a t i o n , C e n t e r f o r D r u g E v a l u a t i o n a n d R e s e a r c h ( C D E R ) . G u i d a n c e f o r I n d u s t r y : A N D A S u b m i s s i o n s R e f u s e t o R e c e i v e f o r L a c k o f J u s t i f i c a t i o n o f I m p u r i t y L i m i t s . A u g u s t 2 0 1 6
1 6 0F o o d a n d D r u g A d m i n i s t r a t i o n , C e n t e r f o r D r u g E v a l u a t i o n a n d R e s e a r c h ( C D E R ) , a n d C e n t e r f o r V e t e r i n a r y M e d i c i n e ( C V M ) . G u i d a n c e f o r I n d u s t r y f o r t h e S u b m i s s i o n D o c u m e n t a t i o n f o r S t e r i l i z a t i o n P r o c e s s V a l i d a t i o n i n A p p l i c a t i o n s f o r H u m a n a n d V e t e r i n a r y D r u g P r o d u c t s . N o v e m b e r 1 9 9 4
1 7 0F o o d a n d D r u g A d m i n i s t r a t i o n , C e n t e r f o r D r u g E v a l u a t i o n a n d R e s e a r c h ( C D E R ) a n d C e n t e r f o r B i o l o g i c s E v a l u a t i o n a n d R e s e a r c h ( C B E R ) . G u i d a n c e f o r I n d u s t r y : A l l o w a b l e E x c e s s V o l u m e a n d L a b e l e d V i a l F i l l S i z e i n I n j e c t a b l e D r u g a n d B i o l o g i c a l P r o d u c t s . J u n e 2 0 1 5
1 8 0F o o d a n d D r u g A d m i n i s t r a t i o n , C e n t e r f o r B i o l o g i c s E v a l u a t i o n a n d R e s e a r c h , C e n t e r f o r D r u g E v a l u a t i o n a n d R e s e a r c h , C e n t e r f o r D e v i c e s a n d R a d i o l o g i c a l H e a l t h , a n d C e n t e r f o r V e t e r i n a r y M e d i c i n e . G u i d a n c e f o r I n d u s t r y : C o n t a i n e r a n d C l o s u r e S y s t e m I n t e g r i t y T e s t i n g i n L i e u o f S t e r i l i t y T e s t i n g a s a C o m p o n e n t o f t h e S t a b i l i t y P r o t o c o l f o r S t e r i l e P r o d u c t s . F e b r u a r y 2 0 0 8
1 9 0F o o d a n d D r u g A d m i n i s t r a t i o n , C e n t e r f o r D r u g E v a l u a t i o n a n d R e s e a r c h ( C D E R ) . G u i d a n c e f o r I n d u s t r y : C h a n g e s t o a n A p p r o v e d N D A o r A N D A . A p r i l 2 0 0 4
2 0 0F o o d a n d D r u g A d m i n i s t r a t i o n , C e n t e r f o r D r u g E v a l u a t i o n a n d R e s e a r c h ( C D E R ) . G u i d a n c e f o r I n d u s t r y : A N D A s : S t a b i l i t y T e s t i n g o f D r u g S u b s t a n c e s a n d P r o d u c t s , Q u e s t i o n s a n d A n s w e r s . M a y 2 0 1 4
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2 2 0E u r o p e a n M e d i c i n e s A g e n c y , C o m m i t t e e f o r M e d i c i n a l P r o d u c t s f o r H u m a n U s e ( C H M P ) . E M A / C H M P / Q W P / 7 9 9 4 0 2 / 2 0 1 1 : R e f l e c t i o n P a p e r o n t h e P h a r m a c e u t i c a l D e v e l o p m e n t o f I n t r a v e n o u s M e d i c i n a l P r o d u c t s C o n t a i n i n g A c t i v e S u b s t a n c e s S o l u b i l i s e d i n M i c e l l a r S y s t e m s .
2 3 0E u r o p e a n M e d i c i n e s A g e n c y , C o m m i t t e e f o r M e d i c i n a l P r o d u c t s f o r H u m a n U s e ( C H M P ) . G u i d e l i n e o n t h e I n v e s t i g a t i o n o f B i o e q u i v a l e n c e . J a n u a r y 2 0 1 0
2 4 0H e a l t h C a n a d a , H e a l t h P r o d u c t s a n d F o o d B r a n c h . G U I D A N C E F O R I N D U S T R Y : P h a r m a c e u t i c a l Q u a l i t y o f A q u e o u s S o l u t i o n s . F e b r a u r y 2 0 0 8
2 5 0F o o d a n d D r u g A d m i n i s t r a t i o n , C e n t e r f o r D r u g E v a l u a t i o n a n d R e s e a r c h ( C D E R ) . G u i d a n c e s D r u g s G e n e r i c s : h t t p s : / / w w w . f d a . g o v / D r u g s / G u i d a n c e C o m p l i a n c e R e g u l a t o r y I n f o r m a t i o n / G u i d a n c e s / u c m 0 6 4 9 9 5 . h t m
2 6 0F o o d a n d D r u g A d m i n i s t r a t i o n , C e n t e r f o r D r u g E v a l u a t i o n a n d R e s e a r c h ( C D E R ) . G e n e r i c D r u g D e v e l o p m e n t : h t t p s : / / w w w . f d a . g o v / D r u g s / D e v e l o p m e n t A p p r o v a l P r o c e s s / H o w D r u g s a r e D e v e l o p e d a n d A p p r o v e d / A p p r o v a l A p p l i c a t i o n s / A b b r e v i a t e d N e w D r u g A p p l i c a t i o n A N D A G e n e r i c s / u c m 1 4 2 1 1 2 . h t m
2 7 0F o o d a n d D r u g A d m i n i s t r a t i o n , C e n t e r f o r D r u g E v a l u a t i o n a n d R e s e a r c h ( C D E R ) , O f f i c e o f G e n e r i c D r u g s . F i l i n g R e v i e w o f A b b r e v i a t e d N e w D r u g A p p l i c a t i o n s , M A P P 5 2 0 0 . 1 4 . S e p t e m b e r 2 0 1 7 .
2 8 0E u r o p e a n M e d i c i n e s A g e n c y , C o m m i t t e e f o r P r o p r i e t a r y M e d i c i n e P r o d u c t s . N o t e f o r G u i d a n c e o n I n - u s e S t a b i l i t y T e s t i n g o f H u m a n M e d i c i n e P r o d u c t s . S e p t e m b e r 2 0 0 1 .
2 9 0E u r o p e a n M e d i c i n e s A g e n c y , C o m m i t t e e f o r P r o p r i e t a r y M e d i c i n e P r o d u c t s . N o t e f o r G u i d a n c e o n I n c l u s i o n o f A n t i o x i d a n t s a n d A n t i m i c r o b i a l P r e s e r v a t i v e s i n M e d i c i n e P r o d u c t s . J a n u a r y 1 9 9 8 .
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