Expedited Access for Premarket Approval (EAP) Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance

FDA Draft Guidance: Expedited Access for Premarket Approval (EAP) Medical Devices On April 23, 2014 the FDA released for comment purposes only, the Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions – Draft Guidance for Industry. Comments should be received by the FDA within 90 days of publication in the Federal Register.

The Expedited Access for Premarket Approval (EAP) is a new “voluntary program for Continue reading

New FDA Draft Guidance Clarifies Standards for Submission of HIV-1 Virology Resistance Data

Draft, Attachment to Guidance on Antiviral Product Development - Conducting and Submitting Virology Studies to the Agency, Guidance for Submitting HIV-1 Resistance DataIn June 2006 the FDA released its Guidance for Industry: Antiviral Product Development – Conducting and Submitting Virology Studies to the Agency available here: http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0183-gdl0002-01.pdf. Since its release the FDA has developed three attachments (available here: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm124470.htm) with the fourth, DRAFT Guidance for Submitting HIV-1 Resistance Data currently open for comment.

The purpose of this new draft guidance is to Continue reading