Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance
By Zachary Brennan -
Published 08 August 2017
With an increased demand for the repackaging of solid oral dosage form drugs into unit-dose containers, the US Food and Drug Administration (FDA) on Tuesday released revised draft guidance on the conditions under which it does not intend to take action regarding stability studies and the expiration date to assign.
Categories: News, US, FDA, Drugs, Packaging, Regulatory intelligence, Regulatory strategy
Tags: expiration date, FDA draft guidance, repackaging
BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics
By Michael Mezher -
Published 15 March 2017
The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics.
Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Packaging
Tags: Mixing, Diluting, Repackaging, Compounding, Outsourcing Facilities, BIO, Pew