Search Results for Repackaging

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Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance By Zachary Brennan - Published 08 August 2017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oral dosage form drugs into unit-dose containers, the US Food and Drug Administration (FDA) on Tuesday released revised draft guidance on the conditions under which it does not intend to take action regarding stability studies and the expiration date to assign.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Tags: expiration date, FDA draft guidance, repackaging

BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics By Michael Mezher - Published 15 March 2017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and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics.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