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ANDA Amendments Cannot Get Mid-Review Communications Like Full Applications - FDA

 
• By Derrick Gingery

Generic industry officials ask that information requests and discipline review letters be issued during ANDA amendment assessments, but the US agency says they are not allowed in GDUFA II.

Sand running through the bulbs of an hourglass measuring the passing time in a countdown to a deadline, on a dark background with copy space.
Industry worries that lack of mid-review communication about minor deficiencies in ANDA amendments could lengthen approval times.

FDA will not issue information requests or discipline review letters while assessing ANDA amendments, even though industry is concerned the policy may result in longer approval times.

Industry representatives told agency officials during an April 10 meeting on generic drug user fee program implementation that they were receiving complete response letters for amendments to generic drug applications...

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