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FDA Form 483 Inspectional Observations Are Not Findings of Wrongdoing

USA - October 24 2016 Since shortly after the U.S. Food and Drug Administration ("FDA") began publishing FDA Form 483 inspectional observations of Section 503B outsourcing...

John D. Kendzior, Emily L. Hussey.

FDA Releases Draft Guidances on What Constitute "Essentially Copies" of Commercially Available or Approved Drug Products

USA - August 4 2016 According to the draft guidance, a drug will be considered "commercially available" if it is a marketed drug product and neither has been...

Alison T. Rosenblum.

FDA Solidifies Its Position on Certain Compounding Issues in New Guidance Documents

USA - June 20 2016 On June 9, 2016, the U.S. Food and Drug Administration ("FDA") published two final guidance documents on drug compounding under Sections 503A and...

Emily L. Hussey.

FDA Clarifies Its Position on Several Compounding Issues in New Draft Guidance Documents

USA - May 12 2016 On April 15, 2016, the U.S. Food and Drug Administration (FDA) announced the release of three new draft guidance documents on drug compounding under...

Alison T. Rosenblum.

FDA publishes revised guidance on product tracing requirements for dispensers

USA - November 4 2015 On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system by November 27, 2023...

Carolyn A. Alenci.