Recently Posted Guidance Documents on Guidance for Industry; Premarket, Emerging Technology; Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC); CGMP, Pharmaceutical Quality

Recently Posted Guidance Documents

Guidance for Industry

8/11/2017 Guidance for Industry: Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products

Premarket, Emerging Technology

8/10/2017 Qualification of Medical Device Development Tools - Guidance for Industry, Tool Developers, and Food and Drug Administration Staff

 

Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC)

8/8/2017 CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports

CGMP, Pharmaceutical Quality

8/8/2017 Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

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