FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

CDER Lists Planned Guidances for 2019

March 13, 2019

CDER plans to release 93 new or revised guidances for drugmakers in 2019, spelling out the center’s current thinking on issues ranging from risk-benefit assessments for opioids to exclusivity periods for generics.

In a newly released guidance agenda, the center lists more than a dozen planned guidances on drug quality and chemistry, manufacturing and controls — including guidances on drug master files, stability considerations for NDAs, ANDAs and BLAs — and using the FDA’s inactive ingredient database.

The center plans to release 14 guidances on generics, including questions and answers on 180-day exclusivity, guidance on evaluating active ingredient sameness in ANDAs and guidance on three-year exclusivity determinations.

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