Industry news

Withdrawn FDA Guidance

On 7 August 2025 CDER announced that it was withdrawing several old (issued before 2010) draft guidances because they were “out of date, thus of little use to the pharmaceutical industry”. Among the guidances that were withdrawn were the following two that have a potential Good Manufacturing Practices impact:

• ‘‘Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients”; issued April 1998
• ‘‘Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment’’; issued November 2003

See http://www.gpo.gov/fdsys/pkg/FR-2013-08-07/pdf/2013-19051.pdf for details.