FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

CDER Lists Planned Guidances for 2019

March 13, 2019
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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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